BEUDAMED
    FDA Recall Terminated

    Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.

    Recall: Z-0155-05 · Initiated September 15, 2004

    Recall

    Recall Number
    Z-0155-05
    Event Number
    30035
    Firm
    GE OEC Medical Systems, Inc
    FEI Number
    1720753
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2004
    Posted
    November 3, 2004
    Terminated
    July 7, 2011
    Address
    384 Wright Brothers Dr, Salt Lake City, UT, 84116-2862

    Description

    Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.

    Reason

    Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.

    Action

    Consignees were notified by letter on 9/15/2004.

    Distribution

    AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.

    Quantity

    114 units