BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1520-2026 · Initiated January 12, 2026

    Recall

    Recall Number
    Z-1520-2026
    Event Number
    98342
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    KRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 12, 2026
    Posted
    March 10, 2026

    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.

    Action

    On or about January 12, 2026 URGENT FIELD SAFETY NOTICE Product Recall letters were sent to customers. Actions to be taken: Review inventory to identify and quarantine any affected product. Return any unused product to the manufacturer. Follow patient management recommendations, if implanted. A custom-made replacement set can be requested. If an affected product is noticed during implantation, another plateau screw from a replacement set or different LINK knee prosthesis package can be used. If this situation occurs, a complaint form must be completed and sent to [email protected]. The replacement of the affected products will begin as soon as replacement products are available. Replacement will not incur any costs to you. Should you have any questions on acquiring replacements for forthcoming surgeries, please contact your local sales representative or customer service for Link products.

    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)