BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0866-2014 · Reported February 5, 2014

    Enforcement

    Recall Number
    Z-0866-2014
    Event ID
    67203
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2014
    Initiation Date
    January 3, 2014
    Classification Date
    January 30, 2014
    Termination Date
    May 16, 2014
    Address
    1800 Pyramid Place, Memphis, TN, 38132, United States

    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.

    Code Info

    TI13J01811

    Distribution

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

    Quantity

    7 units