BEUDAMED
    FDA Enforcement Class II Terminated

    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.

    Recall: Z-0952-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0952-2015
    Event ID
    70032
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    December 3, 2014
    Classification Date
    January 12, 2015
    Termination Date
    September 24, 2015
    Address
    1800 Pyramid Place, Memphis, TN, 38132, United States

    Description

    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.

    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

    Lot # - CA14C107

    Distribution

    US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.

    Quantity

    24 units