BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

    Recall: Z-0890-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0890-2026
    Event ID
    97971
    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
    December 17, 2025
    Initiation Date
    November 10, 2025
    Classification Date
    December 9, 2025
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

    Reason

    The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

    Code Info

    Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;

    Distribution

    US distribution to states of: AL, GA, and TX.

    Quantity

    18 units