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U.S. Department of Health and Human Services

Medical Device Recalls
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Related Medical Device Recalls
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Z-0024-2022 - Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product... 2 10/04/2021 Exactech, Inc.
Z-0023-2022 - TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibia... 2 10/04/2021 Exactech, Inc.
Z-0021-2022 - OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-... 2 10/04/2021 Exactech, Inc.
Z-0019-2022 - OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 2... 2 10/04/2021 Exactech, Inc.
Z-0025-2022 - OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. 2 10/04/2021 Exactech, Inc.
Z-0026-2022 - OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. 2 10/04/2021 Exactech, Inc.
Z-0020-2022 - OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall... 2 10/04/2021 Exactech, Inc.
Z-0022-2022 - OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Produ... 2 10/04/2021 Exactech, Inc.
Z-0027-2022 - ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. 2 10/04/2021 Exactech, Inc.
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