BEUDAMED
    FDA Recall Terminated

    Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.

    Recall: Z-0370-2010 · Initiated May 28, 2009

    Recall

    Recall Number
    Z-0370-2010
    Event Number
    51933
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    NQP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 28, 2009
    Posted
    November 19, 2009
    Terminated
    October 5, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.

    Reason

    The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.

    Action

    Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.

    Distribution

    Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.

    Quantity

    177