BEUDAMED
    FDA Recall Open, Classified

    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

    Recall: Z-1257-2022 · Initiated May 5, 2022

    Recall

    Recall Number
    Z-1257-2022
    Event Number
    90230
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Labeling mix-ups
    Initiated
    May 5, 2022
    Address
    9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445

    Description

    DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

    Reason

    A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

    Action

    On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.

    Distribution

    U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.

    Quantity

    20