BEUDAMED
    FDA Enforcement Class II Ongoing

    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

    Recall: Z-1511-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1511-2026
    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: 16-2840/05;

    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: 16-2840/05; UDI-DI: 04026575359240; Serial/Lot Number: 250513/2083, 250513/2085 , 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097 , 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245 , 251013/3247, 251013/3250, 251013/3251, 251013/3252, 251013/3253, 251105/0013 , 251105/0016, 251105/0018, 251105/0020, 251105/0032, 251105/0034, 251105/0036 , 251105/0037, 251105/0038, 251105/0039, 250513/2106, 250513/2099, 251105/0014 , 251105/0040, 251105/0002, 250513/2087, 250513/2091, 251013/3246, 251105/0019 , 251013/3249, 251105/0011, 251105/0012, 250513/2103, 250513/2105, 251013/3254;

    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

    44 units (1 US, 43 OUS)