BEUDAMED
    FDA Recall Terminated

    Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.

    Recall: Z-0603-2011 · Initiated December 1, 2005

    Recall

    Recall Number
    Z-0603-2011
    Event Number
    54143
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 1, 2005
    Posted
    December 10, 2010
    Terminated
    June 1, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.

    Reason

    The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.

    Action

    The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.

    Distribution

    Worldwide Distribution, including US.

    Quantity

    220