BEUDAMED
    FDA Recall Open, Classified

    LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12

    Recall: Z-1219-2024 · Initiated January 22, 2024

    Recall

    Recall Number
    Z-1219-2024
    Event Number
    93944
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
    FEI Number
    3003386935
    Product Code
    LZO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 22, 2024
    Posted
    February 29, 2024

    Description

    LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12

    Reason

    Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

    Action

    LinkBio Corp issued Urgent: Medical Device Recall letter via email on 1/22/24 to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

    Distribution

    Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.