BEUDAMED
    FDA Recall Terminated

    Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.

    Recall: Z-1658-2008 · Initiated March 13, 2008

    Recall

    Recall Number
    Z-1658-2008
    Event Number
    47238
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 13, 2008
    Posted
    September 16, 2008
    Terminated
    October 15, 2008
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.

    Reason

    The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien

    Action

    Consignees were notified by Urgent Medical Device Removal Notice dated 3/13/08 to discontinue use of the instruments and return to the firm. Operating room managers were sent a separate letter dated 3/13/08 and informed of the possible effects to patients from previous use of this instrument and it was suggested they monitor patients for these effects. If you have any questions contact Mary Hardesty at 1-800-348-9500 or (574) 372-3983.

    Distribution

    Class II Recall - Nationwide Distribution.

    Quantity

    189