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U.S. Department of Health and Human Services

Medical Device Recalls

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The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compound... 2 08/24/2022 Baxter Healthcare Corporation
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1... 1 07/22/2022 Baxter Healthcare Corporation
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-0... 2 03/08/2022 Brainlab AG
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Prod... 2 10/04/2021 Exactech, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULI... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK A... 2 10/04/2021 Exactech, Inc.
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibi... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Produc... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Informati... 2 10/04/2021 Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Ti... 2 10/04/2021 Exactech, Inc.
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