BEUDAMED
    FDA Recall Terminated

    Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855

    Recall: Z-0291-2008 · Initiated October 10, 2007

    Recall

    Recall Number
    Z-0291-2008
    Event Number
    45526
    Firm
    Pioneer Surgical Technology
    FEI Number
    1000115331
    Product Code
    HWR
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 10, 2007
    Posted
    November 27, 2007
    Terminated
    March 31, 2008
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855

    Reason

    The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.

    Action

    Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm.

    Distribution

    Nationwide: including states of California, Florida, Michigan and North Carolina.

    Quantity

    38