BEUDAMED
    FDA Recall Terminated

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    Recall: Z-3102-2017 · Initiated August 4, 2017

    Recall

    Recall Number
    Z-3102-2017
    Event Number
    77930
    FEI Number
    1000116912
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 4, 2017
    Terminated
    June 28, 2023
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758-5445

    Description

    MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58

    Reason

    It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.

    Action

    The firm initiated their recall by telephone and email to their sales representatives and surgeons on 08/04/2017. The letter explained the problem and advised the surgeons that the sales representative would be collecting the devices for return.

    Distribution

    OH, VA

    Quantity

    5 units