BEUDAMED
    FDA Recall Terminated

    Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors.

    Recall: Z-0190-2007 · Initiated October 5, 2006

    Recall

    Recall Number
    Z-0190-2007
    Event Number
    36549
    Firm
    Zimmer Spine, Inc.
    FEI Number
    1000115775
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 5, 2006
    Posted
    November 16, 2006
    Terminated
    October 29, 2007
    Address
    7375 Bush Lake Rd, Minneapolis, MN, 55439-2027

    Description

    Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors.

    Reason

    Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing.

    Action

    Distributors were notified via email with an Urgent Product Recall letter beginning 10/12/2006. Distributors are to return their own inventory and any hospital consignment inventory by October 20, 2006. A Certification Form is also to be faxed back to Zimmer Spine.

    Distribution

    Nationwide and Japan

    Quantity

    159