BEUDAMED
    FDA Enforcement Class II Ongoing

    Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07

    Recall: Z-1379-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1379-2022
    Event ID
    90477
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 20, 2022
    Initiation Date
    May 24, 2022
    Classification Date
    July 12, 2022
    Address
    Oststr. 4-10, Norderstedt, N/A, Germany

    Description

    Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/07

    Reason

    There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

    Code Info

    UDI-DI: 04026575359202 Small, W; 04026575359219 Medium, W; 04026575359226 Large, W; Serial/Lot Numbers: 201002/1683 211025/1543 210202/0275 210302/0308 210314/1872 201002/1687

    Distribution

    Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam

    Quantity

    3785