BEUDAMED
    FDA Recall Terminated

    GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)

    Recall: Z-0001-2007 · Initiated May 31, 2006

    Recall

    Recall Number
    Z-0001-2007
    Event Number
    35637
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 31, 2006
    Posted
    October 3, 2006
    Terminated
    July 27, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)

    Reason

    Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

    Action

    Consignees were notified by letter on 05/31/2006

    Distribution

    Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.

    Quantity

    143 units