BEUDAMED
    FDA Recall 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 · Initiated April 9, 2015

    Recall

    Recall Number
    Z-1597-2015
    Event Number
    70950
    Firm
    Spinal Elements, Inc
    FEI Number
    3004893332
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 9, 2015
    Posted
    May 11, 2015
    Terminated
    June 25, 2015
    Address
    3115 Melrose Dr, Suite 200, Carlsbad, CA, 92010-6690

    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.

    Action

    The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.

    Distribution

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

    Quantity

    588