BEUDAMED
    FDA Recall Open, Classified

    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50

    Recall: Z-2541-2025 · Initiated July 31, 2025

    Recall

    Recall Number
    Z-2541-2025
    Event Number
    97383
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    July 31, 2025
    Posted
    September 8, 2025

    Description

    LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50

    Reason

    Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

    Action

    Waldemar Link notified consignees on about 07/31/2025 via URGENT: MEDCICAL DEVICE RECALL letter. Consignees were instructed to identify any affected units and arranging for their return to LinkBio Corporation, and to also complete and return the response form.

    Distribution

    Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.

    Quantity

    8 units