BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo-Model Replacement Plateau; Item Number: 15-8521/15;

    Recall: Z-1520-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1520-2026
    Event ID
    98342
    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
    March 18, 2026
    Initiation Date
    January 12, 2026
    Classification Date
    March 10, 2026
    Address
    Ost Str. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    Endo-Model Replacement Plateau; Item Number: 15-8521/15;

    Reason

    The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

    Code Info

    Item Number: 15-8521/15; UDI-DI: 04026575383283; Serial/Lot Number: 250805/0020, 250805/0021, 250805/0023, 250805/0024;

    Distribution

    Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

    Quantity

    4 units (OUS only)