BEUDAMED
    FDA Recall Terminated

    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

    Recall: Z-2363-2015 · Initiated May 12, 2015

    Recall

    Recall Number
    Z-2363-2015
    Event Number
    71445
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 12, 2015
    Posted
    August 10, 2015
    Terminated
    October 5, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland

    Reason

    A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.

    Action

    Stryker Orthopaedics notified their branches/agencies via email on 5/12/2015 and sent notification letters and product accountability forms to hospital risk management/branches on 7/15/2015 and 7/16/2015

    Distribution

    US Nationwide

    Quantity

    21 units