BEUDAMED
    FDA Enforcement Class III Terminated

    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.

    Recall: Z-1597-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1597-2015
    Event ID
    70950
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spinal Elements, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    April 9, 2015
    Classification Date
    May 11, 2015
    Termination Date
    June 25, 2015
    Address
    3115 Melrose Dr Suite 200, N/A, Carlsbad, CA, 92010-6690, United States

    Description

    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Lordosed rods are pre-curved to better fit the patient anatomy.

    Reason

    Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.

    Code Info

    Part Number: 60100-045 Lot Numbers: 140086, 140449, 141013

    Distribution

    Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.

    Quantity

    588