BEUDAMED
    FDA Recall Terminated

    Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

    Recall: Z-0859-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-0859-2016
    Event Number
    73139
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    January 11, 2016
    Terminated
    January 20, 2017
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

    Reason

    Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use.

    Action

    Consignees were sent a Medtronic "Medical Device Correction" letter dated January 2016. The letter was addressed to Healthcare Professional. The letter described the problem and the product involved in the recall. Advised consignees to ensure their staff of the action that is being recommended. Requested consignees to complete and return the "Physician Confirmation Form". For additional information they can contact Medtronic Neuromodulation Technical services at 1-800-707-0933 weekends 7 am - 6 Pm Central time.

    Distribution

    Worldwide Distribution, including US Nationwide.

    Quantity

    51,138 (44,006 US; 9,132 OUS)