BEUDAMED
    FDA Recall Terminated

    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

    Recall: Z-0866-2014 · Initiated January 3, 2014

    Recall

    Recall Number
    Z-0866-2014
    Event Number
    67203
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    January 3, 2014
    Posted
    January 30, 2014
    Terminated
    May 16, 2014
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

    Reason

    The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

    Action

    The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.

    Distribution

    US Distribution in the states of CA, NC, TX, IN, NJ, and MI.

    Quantity

    7 units