BEUDAMED
    FDA Enforcement Class II Ongoing

    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

    Recall: Z-2047-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-2047-2023
    Event ID
    92500
    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 5, 2023
    Initiation Date
    March 18, 2021
    Classification Date
    June 30, 2023
    Address
    Oststr. 4-10, N/A, Norderstedt, N/A, N/A, Germany

    Description

    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left

    Reason

    The firm discovered through customer complaints that device segments may not meet specifications.

    Code Info

    Item No. 15/2973/06; UDI-DI: 04026575340736.

    Distribution

    Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

    Quantity

    22 units