BEUDAMED
    FDA Enforcement Class II Ongoing

    Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

    Recall: Z-0749-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0749-2024
    Event ID
    93662
    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
    January 24, 2024
    Initiation Date
    November 30, 2023
    Classification Date
    January 18, 2024
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05

    Reason

    Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

    Code Info

    UDI-DI :04026575245253 Lot / Serial Number: C306165

    Distribution

    US Nationwide distribution in the state of NH.

    Quantity

    1 unit