BEUDAMED
    FDA Enforcement Class II Ongoing

    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

    Recall: Z-0766-2025 · Reported January 1, 2025

    Enforcement

    Recall Number
    Z-0766-2025
    Event ID
    96019
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Encore Medical, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2025
    Initiation Date
    December 18, 2024
    Classification Date
    December 26, 2024
    Address
    9800 Metric Blvd, Austin, TX, 78758-5445, United States

    Description

    EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

    Reason

    5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

    Code Info

    REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086

    Distribution

    US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.

    Quantity

    33