BEUDAMED
    FDA Recall Terminated

    Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V); REF 600-04-180.

    Recall: Z-1746-2008 · Initiated March 26, 2008

    Recall

    Recall Number
    Z-1746-2008
    Event Number
    47527
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 26, 2008
    Posted
    September 1, 2008
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Spine Cyclone anterior cervical plate, 4 Level, 80MM (Ti-6Al-4V); REF 600-04-180.

    Reason

    The screw locking cap may fracture when the surgeon rotates it into the locked position.

    Action

    Consignees were notified via voicemail on 3/26/08 and a letter was sent to all distributors on 3/27/08 informing them that the plate should no longer be used and that all lots are being recalled. A letter dated 6/18/08 was issued to implant physicians recommending patient monitoring. Contact Zimmer Spine at 1-952-857-5636 for assistance.

    Distribution

    Arizona, California, Florida, Georgia, Louisiana, Michigan, Minnesota, Montana, New Hampshire, North Carolina, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin.