BEUDAMED
    FDA Recall Terminated

    Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.

    Recall: Z-0263-2010 · Initiated October 5, 2009

    Recall

    Recall Number
    Z-0263-2010
    Event Number
    53549
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    DZI
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    October 5, 2009
    Posted
    November 16, 2009
    Terminated
    November 30, 2009
    Address
    4100 E. Milham Ave., Kalamazoo, MI, 49001

    Description

    Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.

    Reason

    The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.

    Action

    Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.

    Distribution

    USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.

    Quantity

    93