BEUDAMED
    FDA Recall Terminated

    Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.

    Recall: Z-1746-2010 · Initiated August 25, 2009

    Recall

    Recall Number
    Z-1746-2010
    Event Number
    55613
    Firm
    Alphatec Spine, Inc.
    FEI Number
    2027467
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 25, 2009
    Posted
    June 2, 2010
    Terminated
    June 7, 2010
    Address
    5818 El Camino Real, Carlsbad, CA, 92008

    Description

    Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008. Intended for the temporary stabilization of the anterior spine during the development of fusion in patients.

    Reason

    The recall was initiated after the firm discovered that the affected lot was labeled incorrectly in that the packaging label indicates that the part number of the lot is 61002-026, which corresponds to a two-level Trestle Anterior Cervical Plate implant.

    Action

    Alphatec Spine initiated a recall communication via telephone beginning August 25, 2009. Customers were given an explanation of the problem and instructed to check their inventory for the affected product. The firm indicated that they would arrange to have Federal Express contact customers for pick-up of the affected product(s) and replacement product would be sent out immediately. For further information, contact Alphatec Spine at 1-800-922-1356.

    Distribution

    Nationwide Distribution -- AL, CA, FL, TN, TX and UT.

    Quantity

    13 units