BEUDAMED
    FDA Recall Terminated

    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

    Recall: Z-0040-05 · Initiated August 24, 2004

    Recall

    Recall Number
    Z-0040-05
    Event Number
    29908
    Firm
    Zimmer Spine, Inc.
    FEI Number
    1000115775
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2004
    Posted
    October 23, 2004
    Terminated
    November 3, 2005
    Address
    7375 Bush Lake Rd, Minneapolis, MN, 55439-2027

    Description

    ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

    Reason

    To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected.

    Action

    The product distributed to accounts will be returned to Zimmer Spine. Product will be quarantined pending investigation and determination of appropriate corrective action.

    Distribution

    Product was distributed nationwide throughout the United States. Product was not distributed outside of the United States.

    Quantity

    82 sets