BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 18, 2024

    Recall

    Recall Number
    Z-0766-2025
    Event Number
    96019
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 18, 2024
    Posted
    December 26, 2024
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    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.

    Action

    On 12/18/2024, recall notices were emailed to consignees who were asked to do the following: 1. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to [email protected] If you have questions contact the firm at [email protected]

    Distribution

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

    Quantity

    33