OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Howmedica Osteonics Corp. recalls 12 products

Recall date · record updated Sep 23, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

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.

Company
Howmedica Osteonics Corp.
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).
Who’s affected
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99558…

Products (12)

  1. AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: No UDI-DI Lot P22E159Quantity: 12,156 USRecall no. Z-3195-2026Class II

  2. OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: UDI-DI 07613327037883 Lot 13MFTQuantity: 12,156 USRecall no. Z-3196-2026Class II

  3. ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 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 8H39KQuantity: 12,156 USRecall no. Z-3197-2026Class II

  4. TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573Quantity: 12,156 USRecall no. Z-3198-2026Class II

  5. ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 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-MM10050Quantity: 12,156 USRecall no. Z-3199-2026Class II

  6. DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 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 Quantity: 12,156 USRecall no. Z-3200-2026Class II

  7. 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)

    Codes/lots: 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-Quantity: 12,156 USRecall no. Z-3201-2026Class II

  8. 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)

    Codes/lots: C-M113-1-301 UDI-DI 07613327590074 Lot MH621A C-M113-5-600 No UDI Lot 194593 C-M063-5-800 No UDI Lot RX06358AQuantity: 12,156 USRecall no. Z-3202-2026Class II

  9. SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 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 HOYKQuantity: 12,156 USRecall no. Z-3203-2026Class II

  10. TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)

    Codes/lots: 620-00-28D UDI-DI 07613327313581 Lots MHANP2 MHD1N0Quantity: 12,156 USRecall no. Z-3204-2026Class II

  11. 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)

    Codes/lots: 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 R84K20Quantity: 12,156 USRecall no. Z-3205-2026Class II

  12. 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)

    Codes/lots: 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 X6YEQuantity: 12,156 USRecall no. Z-3206-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls