BEUDAMED
    FDA Enforcement Class II Ongoing

    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

    Recall: Z-1651-2026 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1651-2026
    Event ID
    98431
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 1, 2026
    Initiation Date
    February 11, 2026
    Classification Date
    March 26, 2026
    Address
    Ost Str. 4-10, Norderstedt, N/A, Germany

    Description

    Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

    Reason

    The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

    Code Info

    Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;

    Distribution

    US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

    Quantity

    75 units