BEUDAMED
    FDA Recall Terminated

    Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.

    Recall: Z-1457-05 · Initiated July 29, 2005

    Recall

    Recall Number
    Z-1457-05
    Event Number
    32918
    Firm
    Pioneer Surgical Technology
    FEI Number
    1000115331
    Product Code
    MVH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 29, 2005
    Posted
    August 31, 2005
    Terminated
    October 25, 2005
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.

    Reason

    The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.

    Action

    Distributors were notified via letter dated July 29, 2005 to retrieve all caps from inventory and point of use locations and to return them to Pioneer.

    Distribution

    Nationwide.

    Quantity

    5069