BEUDAMED
    FDA Recall Terminated

    Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.

    Recall: Z-0190-2010 · Initiated May 13, 2009

    Recall

    Recall Number
    Z-0190-2010
    Event Number
    52759
    Firm
    Alphatec Spine, Inc.
    FEI Number
    2027467
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 13, 2009
    Posted
    November 12, 2009
    Terminated
    November 13, 2009
    Address
    5818 El Camino Real, Carlsbad, CA, 92008-8816

    Description

    Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.

    Reason

    Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.

    Action

    Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.

    Distribution

    Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.

    Quantity

    37 devices