BEUDAMED
    FDA Recall Terminated

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    Recall: Z-0435-2021 · Initiated September 18, 2020

    Recall

    Recall Number
    Z-0435-2021
    Event Number
    86526
    Firm
    Merete Medical GmbH Alt-Lankwitz 102 Berlin Germany
    FEI Number
    3002949614
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    September 18, 2020
    Terminated
    May 13, 2021

    Description

    OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

    Reason

    Product may be mislabeled.

    Action

    The recalling firm contacted their importer via email to notify them of the recall. The importer contacted impacted distributors by phone to notify them of the incident and ask that product be shipped back. Customers were provided with overnight shipping labels to ship the product back to the importer. The recalling firm will reconcile returned product quantities against shipping records to ensure all product is returned.

    Distribution

    Product was distributed in US - CA, IL, MD, OH, and NJ

    Quantity

    306 units