BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2641-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2641-2023
    Event ID
    92807
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2023
    Initiation Date
    July 14, 2023
    Classification Date
    September 26, 2023
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    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.

    Code Info

    UDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778

    Distribution

    Domestic distribution to AL, NJ, NV.

    Quantity

    8 units