{"recall":{"id":"fda-device-98700","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Encore Medical, LP recalls 2 products","firm":"Encore Medical, LP","date":"2026-02-16","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.","code":"Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026","quantity":"4","number":"Z-2700-2026","classification":"Class II"},{"name":"Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.","code":"Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060 GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)","quantity":"8","number":"Z-2701-2026","classification":"Class II"}],"reason":"Due to packaging discrepancy with incorrect product size mixed up.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY)    342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL)  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE  1 GL108 Great Lakes Medical Illiniois (IL)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE  1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine  South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC)   342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1  Total 11","nationwide":false,"states":["AL","CO","IA","IL","IN","MI","MT","NC","NE","NY","SD","TX","WY"],"units":"4; 8","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=98700","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"59f04645400b1e5f","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=98700","record":[{"status":"Ongoing","city":"Austin","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98700","recalling_firm":"Encore Medical, LP","address_1":"9800 Metric Blvd","address_2":"N/A","postal_code":"78758-5445","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY)    342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL)  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE  1 GL108 Great Lakes Medical Illiniois (IL)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE  1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine  South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC)   342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1  Total 11","recall_number":"Z-2700-2026","product_description":"Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.","product_quantity":"4","reason_for_recall":"Due to packaging discrepancy with incorrect product size mixed up.","recall_initiation_date":"20260216","center_classification_date":"20260708","report_date":"20260715","code_info":"Model/Catalog Number: 342-19-703 Lot Code: Lot: 177T1057 GTIN: 00888912167703 Expiration Date: 12/07/2026"},{"status":"Ongoing","city":"Austin","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98700","recalling_firm":"Encore Medical, LP","address_1":"9800 Metric Blvd","address_2":"N/A","postal_code":"78758-5445","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"GL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 MW001 Fox Medtech, LLC Colorado (CO), Wyoming (WY), Montana (MT), Counties in Nebraska  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 NE190 Implant Medical Sales, Inc. New York (NY)    342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE 1 SE180 Joint Medical Solutions, L.L.C. Alabama (AL)  342-19-703 177T1057 EMPOWR 3D KNEETM INS, 3R 19MM, VE  1 GL108 Great Lakes Medical Illiniois (IL)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE 2 GL112 Certus Medical LLC Indiana (IN) & Michigan (MI)  341-14-711 135T1060 EMPOWR 3D KNEETM INS, 11L 14MM, VE  1 CE120 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1 NW105 Kinetic Medicine  South Dakota (SD), Eastern Nebraska (NE), Western Iowa (IA)  342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 2 MA102 ProCore Medical LLC - NC North Carolina (NC)   342-14-711 145T1067 EMPOWR 3D KNEETM INS, 11R 14MM, VE 1  Total 11","recall_number":"Z-2701-2026","product_description":"Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.","product_quantity":"8","reason_for_recall":"Due to packaging discrepancy with incorrect product size mixed up.","recall_initiation_date":"20260216","center_classification_date":"20260708","report_date":"20260715","code_info":"Model/Catalog Number: 341-14-711 Lot Code: Lot: 145T1067 and 135T1060   GTIN: 00888912167086 Expiration Date: 12-06-2026 (145T1067) 12-07-2026 (135T1060)"}]}}