BEUDAMED
    FDA Recall Open, Classified

    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

    Recall: Z-2641-2023 · Initiated July 14, 2023

    Recall

    Recall Number
    Z-2641-2023
    Event Number
    92807
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    LPH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 14, 2023
    Posted
    September 26, 2023

    Description

    MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination

    Reason

    Product is labeled with incorrect offset.

    Action

    On July 17, 2023, firm notified consignees via email. Customers were advised to return the affected product to LinkBio. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

    Distribution

    Domestic distribution to AL, NJ, NV.

    Quantity

    8 units