BEUDAMED
    FDA Recall Terminated

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    Recall: Z-2242-2021 · Initiated July 14, 2021

    Recall

    Recall Number
    Z-2242-2021
    Event Number
    88311
    Firm
    Smith & Nephew Orthopaedics Ltd. (Aurora) Aurora, Spa Park Harrison Way Leamington Spa United Kingdom
    FEI Number
    3005975929
    Product Code
    NXT
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 14, 2021
    Terminated
    May 13, 2024

    Description

    smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908. For use during orthopedic surgery.

    Reason

    The nail head may become detached during surgery.

    Action

    The firm notified its consignee by letter on 07/14/2021. The letter explained the issue and the hazard and requested the return of the products.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries GB, NO, CA, AU & NZ.

    Quantity

    47 units