BEUDAMED
    FDA Recall Terminated

    Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    Recall: Z-2360-2010 · Initiated February 1, 2010

    Recall

    Recall Number
    Z-2360-2010
    Event Number
    54625
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    BXN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 1, 2010
    Posted
    September 3, 2010
    Terminated
    March 28, 2011
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump, REF 550-100, Rx, Sterile, Distributed by: Stryker Instruments, Kalamazoo, MI.

    Reason

    Device may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.

    Action

    Stryker Instruments issued an "Urgent Medical Device Recall Notification" letter to consignee risk managers, directors and material managers on February 2, 2010, identifying the affected devices and product issues. The consignees were instructed to: 1) Forward the recall notice and reply form to all affected locations. 2) Review all inventory and quarantine affected product. 3) Destroy all affected product using attached instructions. 4) Complete and return the Business Reply Form to the firm by fax. Stryker Instruments can be contacted at 1-9800-800-4236 ext 4354

    Distribution

    Nationwide Distribution: United States, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, and UT.

    Quantity

    18,826 all products