BEUDAMED
    FDA Recall Open, Classified

    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

    Recall: Z-2049-2023 · Initiated March 18, 2021

    Recall

    Recall Number
    Z-2049-2023
    Event Number
    92500
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    KRO
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 18, 2021
    Posted
    June 30, 2023

    Description

    LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

    Reason

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

    Action

    The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to [email protected].

    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

    13 units