BEUDAMED
    FDA Recall Terminated

    TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery

    Recall: Z-0966-2009 · Initiated November 7, 2008

    Recall

    Recall Number
    Z-0966-2009
    Event Number
    50677
    Firm
    Synthes Spine
    FEI Number
    3005180112
    Product Code
    NQP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 7, 2008
    Posted
    February 3, 2009
    Terminated
    October 5, 2009
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S spinal fusion surgery

    Reason

    the dimensional specifications are incorrect

    Action

    The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information.

    Distribution

    Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea.

    Quantity

    1508 (total)