{"recall":{"id":"fda-device-99558","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Howmedica Osteonics Corp. recalls 12 products","firm":"Howmedica Osteonics Corp.","date":"2026-07-30","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"No UDI-DI Lot P22E159","quantity":"12,156 US","number":"Z-3195-2026","classification":"Class II"},{"name":"OMNIFIT SERIES I ACET. 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UDI-DI 07613327138153 Lots AF3E02I AF3E02S AF3E02Z P1H39Q 5361-6211 UDI-DI 07613327138283 Lots AFZS09F AFZS09G AFZS09S P2N08 PYC30X1 PYW24X1 PZKDHX1 5361-6205 UDI-DI 07613327138177 Lots 1NMMPE 1NNMPE P3K58 P3K58B P3K58F 5361-6207 UDI-DI 07613327138269 Lots AF2S10B AF2S10F AF2S10G P4A241 P4A241X1 P4A241X2 P4A241X3 P4V03 P4V03X1 P4V03X2 P4V03X3 P4V03X4 P4V03X5 PZKDFX1 5361-6209 UDI-DI 07613327138238 Lots AF2K03Z AFZS10S AFZS10U","quantity":"12,156 US","number":"Z-3200-2026","classification":"Class II"},{"name":"ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"61-3258 UDI-DI 07613327038538 Lots 191723 191867 69-2244 UDI-DI 07613327025446 Lots 990V1W D56JV4 D74X5E DX56K2 E67D6N EP10WL KP14HN NN8NM2 P36TXM P95L8X RE4EK0 X82K0D 69-2246 UDI-DI 07613327025453 Lots 8X6EL1 69-2248 UDI-DI 07613327025460 Lots 9J3DPH A41E7D AD39A3 RP673W 69-2850 UDI-DI 07613327025477 Lots MLL1M3 MLLXT1 MLLY6H 69-2852 UDI-DI 07613327025484 Lots MLL0NM MLLAHY 2099-2250 UDI-DI 07613327031430 Lots 1K5VVW 2367AK 3X0NJD 4W4MPL LV80NE 2099-2252 UDI-DI 07613327031447 Lots NV561W PM326V 2099-2256 UDI-DI 07613327031454 Lots 3H5RRK AA7JK0 2099-2861 UDI-DI 07613327031591 Lot MLLVL6 6636-0-419 No UDI Lot 13SFLA 6299-N-332 UDI-DI 07613327138870 Lot 19ECK 6302-H-632 UDI-DI 07613327138979 Lot 15NKT 690-00-22D UDI-DI 07613327025538 Lots 123J5R 194RN0 274HMK 3M77NN 5J8P89 5L82T0 986HVM A23P1X E923WW MLMEW8 MLMTVP MLNPX0 VX6813 690-00-22E UDI-DI 07613327025545 Lots 4100R9 5V78KA 711K4K EY7HL9 KP576W L620XW MD8JH9 T61W43 XA0L27 690-00-28F UDI-DI 07613327025552 Lots 284X4X 2K2DW1 E47WVY MLL8JJ MLLKAY MLLP6K MLLYT7 YE6959 690-00-28G UDI-DI 07613327025583 Lots 6D8274 9N8EWW 690-00-32I UDI-DI 07613327025590 Lots 3A2P68 4A40TV 620-00-28D UDI-DI 07613327313581 Lot MET76R 690-10-28K UDI-DI 07613327024449 Lots MHNRM4 MKRH1M MLAAV7 690-10-22E UDI-DI 07613327024289 Lots 29385D 906WEN DJ7TP1 EK4TK5 LA22KA WL248Y XV01J8 690-10-22F UDI-DI 07613327024357 Lots A6592H L7140Y P103P0 W745P8 690-10-28G UDI-DI 07613327024326 Lot MLL4Y7 690-10-28H UDI-DI 07613327024319 Lots MLKNT7 MLL1YN MLLYXD 690-10-28I UDI-DI 07613327024364 Lots MLL8L9 MLLXWY","quantity":"12,156 US","number":"Z-3201-2026","classification":"Class II"},{"name":"BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"C-M113-1-301 UDI-DI 07613327590074 Lot MH621A C-M113-5-600 No UDI Lot 194593 C-M063-5-800 No UDI Lot RX06358A","quantity":"12,156 US","number":"Z-3202-2026","classification":"Class II"},{"name":"SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"3045-0026 No UDI Lots 12WAHA 12WAHB HOHE HOVX 3045-0028 No UDI Lots 13VAW 13VAWA 3045-0030 No UDI Lots BIYIE HNZY 3045-0032 No UDI Lots BIYIH HOYK","quantity":"12,156 US","number":"Z-3203-2026","classification":"Class II"},{"name":"TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0","quantity":"12,156 US","number":"Z-3204-2026","classification":"Class II"},{"name":"SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"78-5-0910 UDI-DI 07613327366006 Lot 30582401 6074-4022 UDI-DI 07613327031775 Lots 2M5NTY LH25R5 M36N83 6074-4322 UDI-DI 07613327031805 Lot W40E3T 6074-4422 UDI-DI 07613327031812 Lot R84K20","quantity":"12,156 US","number":"Z-3205-2026","classification":"Class II"},{"name":"SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)","code":"73-2710 UDI-DI 07613327033847 Lot NPPV 73-2910 UDI-DI 07613327033854 Lot 14AGFD 73-3110 UDI-DI 07613327033861 Lots 1L45 4JM5 7EL5 AME3 MK74 NTV7 PYHM RE7J VEWJ 73-3508 UDI-DI 07613327033885 Lots HMM5 NLRE 73-3708 UDI-DI 07613327033892 Lots 3467 3D8D PMRHX1 T6YJ T9ME VWDA YAM7 73-3710 UDI-DI 07613327033908 Lots 3W25 DLYP 73-3910 UDI-DI 07613327033915 Lots 14NEYA 1XED 9Y3T D1M9 D2YP EX8T KRT3 KRT3X1 T325 V8X8 X6YE","quantity":"12,156 US","number":"Z-3206-2026","classification":"Class II"}],"reason":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","nationwide":true,"states":[],"units":"12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US; 12,156 US","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99558","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ff8afc80e9f38a19","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99558","record":[{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3195-2026","product_description":"AXLE PIN ASSY LARGE ELBOW COBALT CHROME  Catalog No. C-M112-2-500\t  \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"No UDI-DI Lot P22E159","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3196-2026","product_description":"OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID\t  Catalog No.\t2001-2246    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"UDI-DI 07613327037883  Lot 13MFT","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3197-2026","product_description":"ALL POLY CONSTRAINED INSERT 54MM\t  \t69-2854  \t  NRG KNEE CR\t  \t82-2-0512\t  \t82-2-0518  \t82-2-0912    NRG KNEE P/S\t  \t82-3-0318  \t  SCORPIO + MOBILE BEARING PCS\t  \t78-5-0910    SCORPIO C-DOME PATELLA\t  \t73-2710  \t\t  SCORPIO INSET PATELLA\t  \t73-2610  \t  \t\t  SCORPIO M-DOME PATELLA\t  \t73-0110  \t73-0710  \t73-0910  \t  SCORPIO RECESSED PATELLA 26MM\t  \t3044-0026    SCORPIO TS TIB INS\t  \t72-4-9114  \t\t  SCORPIO TS TIBIAL INSERT\t  \t72-4-0324  \t\t  SCORPIOFLEX TOTAL KNEE CR\t  \t72-16-0512  \t72-16-0518  \t72-16-0912  \t72-16-1112  \t  SERIES II TIBIAL BEAR INSERT NO 11 15MM\t  \t3052-1115  \t  UHR BIPOLAR 26X52mm\t  \tUH1-52-26  \t  UHR BIPOLAR 26X58mm\t  \tUH1-58-26  \t  UHR BIPOLAR 28X48mm\t  \tUH1-48-28    UHR BIPOLAR 28X52mm\t  \tUH1-52-28\t  \t  UHR BIPOLAR 28X55mm\t  \tUH1-55-28\t  \t  UHR BIPOLAR 32X49MM\t  \tUH1-49-32\t  \t  UHR BIPOLAR 32X51MM\t  \tUH1-51-32\t  \t  UHR BIPOLAR 32X52MM\t  \tUH1-52-32\t\t  \t  UHR BIPOLAR 32X54MM\t  \tUH1-54-32  \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"69-2854    UDI-DI 07613327025491    Lots MLKY8A   MLL8E1    82-2-0512    UDI-DI 04546540400611    Lot 23325151 82-2-0518    UDI-DI 04546540400635    Lot 23640051 82-2-0912    UDI-DI 04546540400758    Lot 26862851    82-3-0318    UDI-DI 04546540364319    Lot 28208551    78-5-0910    UDI-DI 07613327366006    Lots 30582401   30582601    73-2710    UDI-DI 07613327033847    Lot 14HDSA    73-2610    UDI-DI 07613327014082    Lots 193307A   193307E    73-0110    UDI-DI 07613327050288    Lot HHPW 73-0710    UDI-DI 07613327050295    Lots 8P83   DL4V 73-0910    UDI-DI 07613327050332    Lot 14NACD    3044-0026    UDI-DI 07613327033779    Lots 14SCVA   14SCVD   14SCVF    72-4-9114    UDI-DI 07613327034875    Lot 8H39KP    72-4-0324    UDI-DI 07613327034356    Lot 23505751    72-16-0512    UDI-DI 07613154020515    Lots 17376651   19093651   23125951   27835951 72-16-0518    UDI-DI 07613154020539    Lot 25621551 72-16-0912    UDI-DI 07613154020652    Lot 17879451 72-16-1112    UDI-DI 07613154020737    Lot 22764851    3052-1115    UDI-DI 07613327034240    Lot MJ7YY6    UH1-52-26    UDI-DI 07613327017168    Lot 5J8PM2    UH1-58-26    UDI-DI 07613327017359    Lots 1R8TNH   414A2L   4W1HD7   AV0J7J   E226XA   E50DAW   M31665   WK1WP2   X90ML6    UH1-48-28    UDI-DI 07613327017014    Lots N046DW   N06WWP   N20WDM   N75AY1   P419XW   RP3D0X   TD218R   V15WA1   VH06PA   VN3P18   VR853H   WM8KJT   XE2ND8   YH0N93    UH1-52-28    UDI-DI 07613327017182    Lot V02MME    UH1-55-28    UDI-DI 07613327017281    Lot R30MME    UH1-49-32    UDI-DI 07613327017069    Lot 324H9H    UH1-51-32    UDI-DI 07613327017120    Lot 9J6N9E    UH1-52-32    UDI-DI 07613327017212    Lots 5D4NMJ   9T612E    UH1-54-32    UDI-DI 07613327017267    Lot MNNAAL","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3198-2026","product_description":"TRIATHLON HINGE INSERT SIZE 4 11MM\t  \t5612-P-411  \t  \t  TRIATHLON HINGE INSERT SIZE 4 13MM\t  \t5612-P-413    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"5612-P-411    UDI-DI 07613327601893    Lot 360958    5612-P-413    UDI-DI 07613327602012    Lot 354573","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3199-2026","product_description":"ABG I ACETABULAR INSERT  HOODED 28mm ID X 48mm\t  \tC-M079-2-801  \t  \t  ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID\t  \tC-M071-6-700  \t  \t  ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD\t  \tC-M071-8-400  \t  \t  BEARING AND AXLE BUSHING ASSY STANDARD ELBOW\t  \tC-M110-1-201  \t  \t  BUSHING AND BEARING USE C-MM100253-00\t  \tC-MM100253-02  \t  \t  DURACON TIB INSERT LG 12MM MED 14MM LAT\t  \tC-M066-3-000  \t  \t  EXETER WINGLESS CENTRALISER FOR C-M082-7-302\t  \tC-M082-7-303  \t  \t  EXETER WINGLESS CENTRALIZER XSM\t  \tC-M107-5-301  \t  \t  GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm\t  \tC-MM100616-02  \t  \t  GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm\t  \tC-MM100616-03  \t  \t  GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm\t  \tC-MM100616-01  \t  \t  GMRS SML POLY TIBIA 11MM CASE 100520\t  \tC-MM100520-03  \t  \t  GMRS SML POLY TIBIA 16MM CASE 100520\t  \tC-MM100520-04  \t  \t  GMRS SML POLY TIBIA 8MM CASE 100520\t  \tC-MM100520-02  \t  \t  GMRS SML TIBIA  11MM WITH CASE 100411\t  \tC-MM100411-03  \t  \t  GMRS SML TIBIA  14MM WITH CASE 100411\t  \tC-MM100411-04  \t  \t  GMRS SML TIBIA  8MM WITH CASE 100411\t  \tC-MM100411-02  \t  \t  GMRS TIB INSRT SML 10MM WITH CASE 100507\t  \tC-MM100507-04  \t  \t  GMRS TIB INSRT SML 16MM WITH CASE 100507\t  \tC-MM100507-06  \t  \t  KALI TIBIAL INSERT LARGE RIGHT 8mm\t  \tC-M071-6-601  \t  \t  KRH REV TIB INS 16mm THK .655 DIA STEM\t  \tC-M113-5-603  \t  \t  MRH KNEE TIBIAL INSERT FOR THIN POST\t  \tC-M067-3-103  \t  \t  MRS RADIAL BUSHING FORITH C-M107-7-800\t  \tC-M107-7-801  \t  \t  SELF-PRESSURIZING GLENOID SIZE 9\t  \tC-M064-4-300  \t  \t  TRIATHLON NO. 9 TIBIAL INSERT 11MM\t  \tC-M067-5-003  \t  \t  TRIATHLON NO. 9 TIBIAL INSERT 9MM\t  \tC-M067-5-002  \t  \t  TRIDENT ALL POLY CUP 44 X 66MM\t  \tC-M066-0-901  \t  \t  TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID  UH1\t  \tC-M104-2-002  \t  \t  TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID  UH1\t  \tC-M104-2-003  \t  \t  UHR BIPOLAR 22X38MM\t  \tUH1-38-22    UHR BIPOLAR 22X40MM\t  \tUH1-40-22    UHR BIPOLAR 22X41MM\t  \tUH1-41-22    UHR BIPOLAR 22X42MM\t  \tUH1-42-22    UHR BIPOLAR 22X43MM\t  \tUH1-43-22    UHR BIPOLAR 22X45MM\t  \tUH1-45-22    UHR BIPOLAR 26X41mm\t  \tUH1-41-26  \t  UHR BIPOLAR 26X42mm\t  \tUH1-42-26  \t  UHR BIPOLAR 26X43mm\t  \tUH1-43-26  \t  UHR BIPOLAR 26X44mm\t  \tUH1-44-26  \t  UHR BIPOLAR 26X45mm\t  \tUH1-45-26  \t  UHR BIPOLAR 26X46mm\t  \tUH1-46-26    UHR BIPOLAR 26X47mm\t  \tUH1-47-26  \t  UHR BIPOLAR 26X48mm\t  \tUH1-48-26  \t  UHR BIPOLAR 28X42mm\t  \tUH1-42-28  \t  UHR BIPOLAR 28X44mm\t  \tUH1-44-28  \t  UHR BIPOLAR 28X45mm\t  \tUH1-45-28    UHR BIPOLAR 28X46mm\t  \tUH1-46-28    UHR BIPOLAR 28X47mm\t  \tUH1-47-28    UHR BIPOLAR 28X48mm\t  \tUH1-48-28    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"C-M079-2-801    No UDI   Lot G3264034    C-M071-6-700    No UDI    Lot G3043883    C-M071-8-400    No UDI   Lot G3043878    C-M110-1-201    UDI-DI 07613327504811    Lot 573P37    C-MM100253-02    No UDI   Lot N8873H    C-M066-3-000    No UDI   Lot RX06630A    C-M082-7-303    No UDI   Lot L6237    C-M107-5-301    No UDI    Lot 193607    C-MM100616-02    No UDI   Lot 195261    C-MM100616-03    No UDI   Lot 195262    C-MM100616-01    No UDI   Lot 195260    C-MM100520-03    No UDI   Lot 195081    C-MM100520-04    No UDI   Lot 195082    C-MM100520-02    No UDI   Lot 195080    C-MM100411-03    No UDI   Lot 194962    C-MM100411-04    No UDI   Lot 194963    C-MM100411-02    No UDI   Lot 194961    C-MM100507-04    No UDI   Lot LNH795    C-MM100507-06    No UDI   Lot LNH797    C-M071-6-601    No UDI   Lot G3055684    C-M113-5-603    No UDI   Lot 194594    C-M067-3-103    No UDI   Lot MHP0AX    C-M107-7-801    No UDI   Lot 193479    C-M064-4-300    No UDI   Lot RX06443A    C-M067-5-003    No UDI   Lot RX06750D    C-M067-5-002    No UDI   Lot RX06750C    C-M066-0-901    No UDI   Lot RX06609B    C-M104-2-002    No UDI    Lot 192371    C-M104-2-003    No UDI    Lot 192370    UH1-38-22    UDI-DI 07613327016789    Lots 2A01TA   430715   49510K   7E5X23   852J98   D23664   NE659N    UH1-40-22    UDI-DI 07613327016796    Lots 128LXW   16182H   1J5955   1T8203   2137N4   2541YM   2Y52Y2   4E19VD   4K7XYL   577M4L   5D3AVR   746AV4   7V8J0V   828TAR   875M72   8V63LX   9A3W5N   A91P07   DL4D38   LW709R   RA6A1H   VT4K59   X95RTV    UH1-41-22    UDI-DI 07613327016819    Lots 343653   4P1TR7   521MLK   7Y8HEA   975A6Y   AR0KX5   E788E6   KL1YTE   KN0086   P043ME   PL4L5M    UH1-42-22    UDI-DI 07613327016833    Lots 1R2VD1   2E84HD   2X333W   4L5YMY   6J2W2P   7238R2   7883W1   7H2L8M   8K315D   AK2P91   ET3HWR   L16J85   L93PY2   ME1485   MY1N20   P987D0   R92PDW   TM0KR0   X884ET   XD3961   YK39TT    UH1-43-22    UDI-DI 07613327016840    Lots 11138V   23005R   481KR9   516JLV   761T5M   9W3NWV   DA0W51   EK6069   KP0AAD   MD1Y5V   NT68KL   RT8N8H   RY828P    UH1-45-22    UDI-DI 07613327016901    Lots 8Y0KWH   HR869M   R7168K   WR4MT4    UH1-41-26    UDI-DI 07613327016802    Lots 157V1T   1D33YX   1K1E6M   1R5LWT   218RED   254MT3   287D4A   2K7HXW   2X5MTA   3J1A39   3K3P0T   473K4V   5A1T5N   5D6KJ5   5V7H82   6J8XKT   6W1MKA   8R29TH   9T7N8Y   AL5K8M   AW02V8   DT8JEW   H04PHL   JR6R9L   LN70PY   MA6M6E   PE7T6P   PY8PLH   RY49EW   T1497X   V70PNP   VJ6WXM   X82M1D    UH1-42-26    UDI-DI 07613327016826    Lots 186JE6   5Y1RL7   618AMX   7J0XET   MLKT5A   MLL022   MLL05K   R50NW2    UH1-43-26    UDI-DI 07613327016864    Lots 192J0R   1D45L5   1H5V53   2P2A99   2V6D0R   3248V2   334851   386P0V   3N33VT   402RP3   4644KD   4J5Y6H   4L3JPP   5H1A45   5Y2422   626J60   6E33NR   6J30X2   6M2KK8   6V092N   761EJP   7820L1   791NPH   7D0H4K   7K28Y8   7K63EE   7N7WX1   817AJJ   8J6TAL   8L6R73   8T3XDK   983JDR   998H5N   9E631T   A93KWD   AY40L3   DJ105H   E521L6   EX5DA9   HW7XYK   J94M7R   JT565R   JX0L8R   K939KP   KA30HV   KE5770   KP1Y0E   KV3L3H   MD76WR   MJ1DY9   MK2MN3   MLL54K   MLL65N   MLLV64   MR6D42   MW2J8W   N314DK   NP48X0   P147V0   P502R8   P92DV1   RL1TL1   RN8NM1   T66JK4   TA20N9   TT3EJR   TV197Y   TY7YV5   V68NXH   V91EK1   VW74NJ   VX5T02   VY0525   WA0VRE   WT7P1A   X48P1Y   Y63LYJ   Y648WL   YE3W2X   YJ6PHM   YL3HVY   YL6L7K   YX8NTJ    UH1-44-26    UDI-DI 07613327016888    Lots 336652   581XTY   5H1YRH   640Y4R   7Y7H14   9J7T4L   A881HX   JN7TXM   KT4P91   LJ44JX   M52APN   MLL2PT   MLL5X1   MLLD4R   MLLPK1   MLLV2Y   NR773K   NV0NVX   PD7P36   R74D1D   T31P16   VK7JL5   W91ENE   XD45XY   XN8EWL   Y385N4   YN1AJN    UH1-45-26    UDI-DI 07613327016925    Lots 056MNE   059MNE   188AWK   243WTY   352XY0   442K1P   8L58NK   AJ0H2R   AN15H5   HX6PAR   HY2V81   L50T23   MLL0AE   MLL5J4   MLL9TV   MLLKNT   N88PKJ   P31A9Y   RJ8JPR    UH1-46-26    UDI-DI 07613327016949    Lots 1839Y2   1M2AX3   1P2E82   1V5AN9   226AWD   232X83   2465J7   2K0P93   2R3XD6   3614YL   394D8M   3P7091   4V2PVP   5389M0   5N2N75   9X7YK5   A35V7K   DW3J8W   DY85VA   E242NY   H07J22   JV88X1   L04PPV   LY44K5   MLL50M   MLL789   MLLA53   NE45DD   V94NTT   YY5N98    UH1-47-26    UDI-DI 07613327016987    Lots 1Y2K34   21197T   3E0A48   4E7MKW   7K1VLW   A58HN9   J38RE2   J60A4E   LT43X0   M15HKN   MK442Y   MLL2LR   MLL52N   MLLRMW   MLLVRW   MLLWVH   XD724J    UH1-48-26    UDI-DI 07613327017007    Lots 1J8K9L   2Y6JK3   350D6V   3845V3   3D6216   44827N   580Y68   726W7P   7L7TPP   8E7A1J   9V8P94   9Y6HML   H88E74   K54MN4   L783M7   MLL3E9   MLL52W   MP56YN   N00HDA   N26TW7   TR4TT5   W016KY   XJ48DN   YA4YPN    UH1-42-28    UDI-DI 07613327016857    Lots 1R5MDV   275NEA   2V6KMY   4215LV   MLKEHT   MLLJ5X   MLLJK9   MLLV75    UH1-44-28    UDI-DI 07613327016895    Lots 106X12   121A72   123MX4   138KNV   1401YE   1429X2   154N34   1740KE   1830AR   186WEL   1D8LYA   1E4HK2   1E6W32   1E7RRN   1H1P69   1K10H5   1K58A6   1K63LK   1M1W89   1M6JWR   1N6VPP   1R8333   1V4LXR   1X8R7X   1Y2V83   1Y7DPY   201MY5   2116XX   2286V1   25090N   251WMR   2550NN   261Y8Y   287N2R   2D4N58   2X5T7Y   335351   335EXD   391JXR   3K6YR2   444636   4E45R8   4K15YY   4L17DL   4L29A4   4M7J5A   4N2091   4P3L83   4T85VA   4W227H   518WTR   521K2M   5246AR   5325D6   534JYN   555249   558TVA   581YM9   5D1Y5V   5H0EXH   5K0AMY   5P0H6D   5R3H24   5V2RJ0   600TDM   623LA2   6370A6   681Y0M   6885NJ   693MRX   698Y2M   6L4LT7   6N4J52   6T3JAY   6V19AE   6V6DW2   6W0A59   7307MN   758K2A   768V6X   7D5MN2   7L230N   7M6YVP   7X2PH3   7X7XM0   8125RN   867YNX   886V7A   8E6V9P   8M114H   8M4W64   8R438X   8X4PRJ   971KAN   987WJ0   9H673H   9K656K   9V0L0L   A56J67   A85T4Y   A86V5E   AA7VL4   AM3PPW   AW6JML   DD37HD   DH5N6T   DL5E4X   DR69YE   E47VAT   EA6WY1   EK5N6A   EK8KDD   EN17M3   ER2VAV   HW14NW   J477D9   J63M24   J644K6   JE7K73   JT2PYD   K47JDR   KD174L   L548RP   LE83EE   LH10XA   LM74JP   LR3KT5   LV0PP9   M45LKM   MLKMWA   MLL0X7   MLL3T3   MLL3X8   MLL3YN   MLL5V9   MLL6E1   MLL70V   MLLA90   MLLDXM   MLLEEY   MLLLKA   MLLNDM   MLLR0R   MLLY2V   MT2YK4   MT56MX   N082LN   N35W9W   N4476X   N60KXY   N780A7   N80J7M   NR5X7N   NW7H6M   PN3K4T   PV87N1   R20NVJ   RM8HJJ   RY4JDM   T6297W   T73HN0   TP366X   V281XV   V64XWE   V95MVD   VA7769   VL3RJJ   VP8E88   W33XH8   W969RX   WD03AK   WJ4YYD   WK2AHL   WW6MVP   X16M08   XM319D   XN437D   Y703W8   YJ012E   YV08TH   YY4TKX    UH1-45-28    UDI-DI 07613327016918    Lots 1A3013   360RPN   486EJ1   4N85AM   D6348Y   EY829J   MLL1V3   MLL210   MLL24J   MLL44A   MLL5RM   MLL94Y   MLLDXY   MLLJRN   MLLVWK   MLLW3M   MLLY7V   X43WJN    UH1-46-28    UDI-DI 07613327016956    Lots 1804DD   29772K   2E5PX4   3402DJ   3P0NDP   4H0W7N   4J5R3M   4K0NDA   5818XA   5R5H8L   6N77PT   6T493L   7K0L36   7L1KRT   8015WY   802XY1   8P7D00   905HH2   AD0E56   D3227P   E83XET   EV4W50   HT21XV   JP0TKR   L00E8N   M25670   MLL0Y0   MLL1W9   MLL46R   MLL499   MLL602   MLL8Y7   MLLAYE   MLLDY9   MLLJWN   MLLK40   MLLKEH   MLLNE3   MLLRL2   MLLV8T   MLLVTD   MLLXV3   MR613J   NT30DY   P72N17   VE411K   WH517T   XH01PP   Y66HVE   YE5XLP    UH1-47-28    UDI-DI 07613327016970    Lots 2821VP   2N68HT   3682T6   3M0Y7N   4E58YD   661DW6   8K6225   8M60J8   9D22DE   9Y0X3H   A68HK5   AL4LYE   J60DLA   KM65D9   LJ3RRT   MLL8V0   MLL984   MLLH9P   MLLLLD   MLLND6   PV1K03   PW100N   TD5KRD   WX0R02    UH1-48-28    UDI-DI 07613327017014    Lots 1831VA   1M4NYV   1T0L93   1W0E1J   254N4A   294M71   2A2RJ0   2T45AP   3K8VM4   3T6PD5   3Y8DJX   437ANA   448V4T   4623VM   484LE9   4X0M53   5D50WT   5L074T   5T0PX8   6E2MX7   6K5Y7V   6L43JP   7A1HVY   8J8DDN   975VXR   9786P2   9D6M48   9M6KHT   9T2991   9X5MJ3   A228M1   A54PLW   A77V1M   AV5ANE   AX18R8   DK0M6J   DY3LR8   E600KE   EY5P9V   H558EP   H63W11   HP74LE   J72DLP   J76YJ6   JK7JY4   JL1T01   K47WL6   K728DH   KT3K27   L35VMM   M15D88   ML731E   MLL18D   MLL562   MLL6MH   MLL74R   MLLM4T   MLLMWV   MLLNTV   MLLPV9   MLLV38   MLLX14","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3200-2026","product_description":"DURACON XL ANGLED TIB INS 11/14MM\t  \tC-M064-1-300  \t  SELF-PRESSURIZING GLENOID SIZE 8\t  \tC-M062-6-800  \tC-M062-7-500\t  \tC-M063-2-600  \t  SELF-PRESSURIZING GLENOID SIZE 9\t  \tC-M063-5-000  \t  SHOULDER - GLENOID #11\t  \t5361-6111    SHOULDER - GLENOID #5\t  \t5361-6105    SHOULDER - GLENOID #7\t  \t5361-6107  \t  SHOULDER - GLENOID #9\t  \t5361-6109    SHOULDER - KEELED GLENOID #11\t  \t5361-6211    SHOULDER - KEELED GLENOID #5\t  \t5361-6205    SHOULDER - KEELED GLENOID #7\t  \t5361-6207  \t  SHOULDER - KEELED GLENOID #9\t  \t5361-6209      \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"C-M064-1-300    No UDI   Lot RX06413A    C-M062-6-800    No UDI    Lot RX06268A  C-M062-7-500    No UDI   Lot RX06275A C-M063-2-600    No UDI    Lot RX06326A    C-M063-5-000    No UDI   Lots RX06350A   RX06350AA    5361-6111    UDI-DI 07613327138191    Lots AFZT00U   AFZT00Z   P2N04B   P3K57   P3K57B   P3K57F   PYE43B   PZA70F   PZA70U    5361-6105    UDI-DI 07613327138214    Lots AF2S09U   AF2S09Z   P1H41   P4T02   P4T02X1   P4T02X2   P4T02X3   P4T02X4   P4T02X5   P4T02X6    5361-6107    UDI-DI 07613327138207    Lots AF3E00   AF3E00B   AF3E00F   AF3E00G   AF3E00Q   AF3E00S   P4A238   P4A238X1   P4A238X2   P4A238X3   P4A238X4   P4A238X5   P4A238X6   P4A238X7   P4A238X8   P4L09   P4L09X1   P4L09X10   P4L09X2   P4L09X3   P4L09X4   P4L09X5   P4L09X6   P4L09X7   P4L09X8   P4L09X9   P4N06   P4N06X1   P4N06X2   P4N06X3   P4N06X4   P4N06X5   P4N06X6   P4N06X7   P4T03   P4T03X1   P4T03X2   P4T03X3   P4T03X4   P4T03X5   P4T03X6   P4T03X7   P4T03X8   P4V01   P4V01X1   P4V01X2   P4V01X3   P4V01X4   P4V01X5   P4V01X6   P4V01X7   P4V01X8    5361-6109    UDI-DI 07613327138153    Lots AF3E02I   AF3E02S   AF3E02Z   P1H39Q    5361-6211    UDI-DI 07613327138283    Lots AFZS09F   AFZS09G   AFZS09S   P2N08   PYC30X1   PYW24X1   PZKDHX1    5361-6205    UDI-DI 07613327138177    Lots 1NMMPE   1NNMPE   P3K58   P3K58B   P3K58F    5361-6207    UDI-DI 07613327138269    Lots AF2S10B   AF2S10F   AF2S10G   P4A241   P4A241X1   P4A241X2   P4A241X3   P4V03   P4V03X1   P4V03X2   P4V03X3   P4V03X4   P4V03X5   PZKDFX1    5361-6209    UDI-DI 07613327138238    Lots AF2K03Z   AFZS10S   AFZS10U","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3201-2026","product_description":"ACETABULAR CUP UHMWPE\t  \t61-3258  \t  ALL POLY CONSTRAINED INSERT 44MM\t  \t69-2244  \t  ALL POLY CONSTRAINED INSERT 46MM\t  \t69-2246  \t  ALL POLY CONSTRAINED INSERT 48MM\t  \t69-2248  \t  ALL POLY CONSTRAINED INSERT 50MM\t  \t69-2850  \t  ALL POLY CONSTRAINED INSERT 52MM\t  \t69-2852  \t  CONSTRAINED ACETABULAR INSERTS 22MM 50MM\t  \t2099-2250  \t  CONSTRAINED ACETABULAR INSERTS 22MM 52MM\t  \t2099-2252  \t  CONSTRAINED ACETABULAR INSERTS 22MM 56MM\t  \t2099-2256  \t  CONSTRAINED ACETABULAR INSERTS 28MM 61MM\t  \t2099-2861  \t  EIUS UNI TIB SMALL RM/LL 9MM\t  \t6636-0-419  \t  PCA CONST LINER 32MM NEUTRAL C - SHELL\t  \t6299-N-332  \t  SYS 12 CONST LINER 32ID 10 DEG P6 +4MM\t  \t6302-H-632  \t  TRIDENT 0 DEG CONSTRAINED INSERT 22D\t  \t690-00-22D  \t  TRIDENT 0 DEG CONSTRAINED INSERT 22E\t  \t690-00-22E  \t  TRIDENT 0 DEG CONSTRAINED INSERT 28F\t  \t690-00-28F  \t  TRIDENT 0 DEG CONSTRAINED INSERT 28G\t  \t690-00-28G  \t  TRIDENT 0 DEG CONSTRAINED INSERT 32I\t  \t690-00-32I    TRIDENT 0¿ POLY INSERT 28mm ID\t  \t620-00-28D  \t  TRIDENT CONSTR ACET INSERT\t  \t690-10-28K    TRIDENT CONSTRAINED INSERT\t  \t690-10-22E  \t690-10-22F  \t690-10-28G  \t690-10-28H  \t690-10-28I    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"61-3258    UDI-DI 07613327038538    Lots 191723   191867    69-2244    UDI-DI 07613327025446    Lots 990V1W   D56JV4   D74X5E   DX56K2   E67D6N   EP10WL   KP14HN   NN8NM2   P36TXM   P95L8X   RE4EK0   X82K0D    69-2246    UDI-DI 07613327025453    Lots 8X6EL1    69-2248    UDI-DI 07613327025460    Lots 9J3DPH   A41E7D   AD39A3   RP673W    69-2850    UDI-DI 07613327025477    Lots MLL1M3   MLLXT1   MLLY6H    69-2852    UDI-DI 07613327025484    Lots MLL0NM   MLLAHY    2099-2250    UDI-DI 07613327031430    Lots 1K5VVW   2367AK   3X0NJD   4W4MPL   LV80NE    2099-2252    UDI-DI 07613327031447    Lots NV561W   PM326V    2099-2256    UDI-DI 07613327031454    Lots 3H5RRK   AA7JK0    2099-2861    UDI-DI 07613327031591    Lot MLLVL6    6636-0-419    No UDI   Lot 13SFLA    6299-N-332    UDI-DI 07613327138870    Lot 19ECK    6302-H-632    UDI-DI 07613327138979    Lot 15NKT    690-00-22D    UDI-DI 07613327025538    Lots 123J5R   194RN0   274HMK   3M77NN   5J8P89   5L82T0   986HVM   A23P1X   E923WW   MLMEW8   MLMTVP   MLNPX0   VX6813    690-00-22E    UDI-DI 07613327025545    Lots 4100R9   5V78KA   711K4K   EY7HL9   KP576W   L620XW   MD8JH9   T61W43   XA0L27    690-00-28F    UDI-DI 07613327025552    Lots 284X4X   2K2DW1   E47WVY   MLL8JJ   MLLKAY   MLLP6K   MLLYT7   YE6959    690-00-28G    UDI-DI 07613327025583    Lots 6D8274   9N8EWW    690-00-32I    UDI-DI 07613327025590    Lots 3A2P68   4A40TV    620-00-28D    UDI-DI 07613327313581    Lot MET76R    690-10-28K    UDI-DI 07613327024449    Lots MHNRM4   MKRH1M   MLAAV7    690-10-22E    UDI-DI 07613327024289    Lots 29385D   906WEN   DJ7TP1   EK4TK5   LA22KA   WL248Y   XV01J8 690-10-22F    UDI-DI 07613327024357    Lots A6592H   L7140Y   P103P0   W745P8 690-10-28G    UDI-DI 07613327024326    Lot MLL4Y7 690-10-28H    UDI-DI 07613327024319    Lots MLKNT7   MLL1YN   MLLYXD 690-10-28I    UDI-DI 07613327024364    Lots MLL8L9   MLLXWY","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3202-2026","product_description":"BEARING AND AXLE BUSHING ASSY STD ELBOW\t  \tC-M113-1-301  \t  KRH REV TIB INS 16mm THK .640 DIA STEM\t  \tC-M113-5-600  \t  SELF-PRESSURIZING GLENOID SIZE 9\t  \tC-M063-5-800  \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"C-M113-1-301    UDI-DI 07613327590074    Lot MH621A    C-M113-5-600    No UDI   Lot 194593    C-M063-5-800    No UDI   Lot RX06358A","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3203-2026","product_description":"SCORPIO RECESSED METAL BACKED PATELLA\t  \t3045-0026  \t3045-0028  \t3045-0030  \t3045-0032    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"3045-0026    No UDI   Lots 12WAHA   12WAHB   HOHE   HOVX 3045-0028    No UDI   Lots 13VAW   13VAWA 3045-0030    No UDI   Lots BIYIE   HNZY 3045-0032    No UDI   Lots BIYIH   HOYK","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3204-2026","product_description":"TRIDENT 0¿ POLY INSERT 28mm ID\t  \t620-00-28D    \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"620-00-28D    UDI-DI 07613327313581    Lots MHANP2   MHD1N0","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3205-2026","product_description":"SCORPIO + MOBILE BEARING PCS\t  \t78-5-0910  \t  SYSTEM ONE BIPOLAR 40MM\t  \t6074-4022    SYSTEM ONE BIPOLAR 43MM\t  \t6074-4322  \t  SYSTEM ONE BIPOLAR 44MM\t  \t6074-4422      \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"78-5-0910    UDI-DI 07613327366006    Lot 30582401    6074-4022    UDI-DI 07613327031775    Lots 2M5NTY   LH25R5   M36N83    6074-4322    UDI-DI 07613327031805    Lot W40E3T    6074-4422    UDI-DI 07613327031812    Lot R84K20","more_code_info":""},{"status":"Ongoing","city":"Mahwah","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99558","recalling_firm":"Howmedica Osteonics Corp.","address_1":"325 Corporate Dr","address_2":"N/A","postal_code":"07430-2006","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.","recall_number":"Z-3206-2026","product_description":"SCORPIO C-DOME PATELLA\t  \t73-2710  \t73-2910  \t  SCORPIO U-DOME PATELLA\t  \t73-3110  \t73-3508  \t73-3708  \t73-3710  \t73-3910      \t  Orthopaedic implant components manufactured from UHMWPE (polyethylene)","product_quantity":"12,156 US","reason_for_recall":"Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.","recall_initiation_date":"20260730","center_classification_date":"20260916","report_date":"20260923","code_info":"73-2710    UDI-DI 07613327033847    Lot NPPV 73-2910    UDI-DI 07613327033854    Lot 14AGFD    73-3110    UDI-DI 07613327033861    Lots 1L45   4JM5   7EL5   AME3   MK74   NTV7   PYHM   RE7J   VEWJ 73-3508    UDI-DI 07613327033885    Lots HMM5   NLRE 73-3708    UDI-DI 07613327033892    Lots 3467   3D8D   PMRHX1   T6YJ   T9ME   VWDA   YAM7 73-3710    UDI-DI 07613327033908    Lots 3W25   DLYP 73-3910    UDI-DI 07613327033915    Lots 14NEYA   1XED   9Y3T   D1M9   D2YP   EX8T   KRT3   KRT3X1   T325   V8X8   X6YE","more_code_info":""}]}}