BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

    Recall: Z-1514-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1514-2026
    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: 16-2840/07;

    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: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;

    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

    31 units (OUS only)