BEUDAMED
    FDA Recall Terminated

    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.

    Recall: Z-1014-04 · Initiated May 21, 2004

    Recall

    Recall Number
    Z-1014-04
    Event Number
    29200
    Firm
    Zimmer Spine, Inc.
    FEI Number
    1000115775
    Product Code
    HWX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2004
    Posted
    February 24, 2005
    Terminated
    November 3, 2005
    Address
    7375 Bush Lake Rd, Minneapolis, MN, 55439-2027

    Description

    Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.

    Reason

    The recalled bone taps could break inside the vertebral body during the tapping process.

    Action

    Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices.

    Distribution

    The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.

    Quantity

    55 units