BEUDAMED
    FDA Recall Terminated

    Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138

    Recall: Z-0786-05 · Initiated February 8, 2005

    Recall

    Recall Number
    Z-0786-05
    Event Number
    31145
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 8, 2005
    Posted
    May 3, 2005
    Terminated
    May 20, 2005
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138

    Reason

    The device has the potential to overheat and cause patient burns during use.

    Action

    All consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor)

    Distribution

    740 domestic consignees

    Quantity

    28935 boxes, 5 units per box.