BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

    Recall: Z-1513-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1513-2026
    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 SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;

    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: 16-2840/02; UDI-DI: 04026575359233; Serial/Lot Number: 250925/0640 , 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653 , 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681 , 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691, 250925/0693 , 250925/0694, 251110/3293, 250925/0660, 250925/0661, 250925/0684, 250925/0685 , 250925/0657, 250925/0663, 250925/0659, 250925/0678, 251110/3288, 251110/3292 , 251110/3303, 251110/3313, 250925/0683, 250925/0674, 250925/0644, 250925/0665 , 250925/0668, 250925/0671, 250925/0673, 250925/0676, 250925/0664 , 250925/0651 , 251110/3297, 251110/3289, 250925/0639, 250925/0648, 250925/0688, 250925/0696;

    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

    49 units (OUS only)