BEUDAMED
    FDA Recall Terminated

    Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.

    Recall: Z-0598-2010 · Initiated July 6, 2009

    Recall

    Recall Number
    Z-0598-2010
    Event Number
    53982
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 6, 2009
    Posted
    January 11, 2010
    Terminated
    October 25, 2010
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.

    Reason

    The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.

    Action

    Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.

    Distribution

    Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.

    Quantity

    5438 of all products