BEUDAMED
    FDA Recall Terminated

    Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).

    Recall: Z-1324-2015 · Initiated February 20, 2015

    Recall

    Recall Number
    Z-1324-2015
    Event Number
    70576
    Firm
    TITAN SPINE, LLC
    FEI Number
    3006340236
    Product Code
    OVE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 20, 2015
    Posted
    March 26, 2015
    Terminated
    April 17, 2015
    Address
    6140 W Executive Dr, Suite A, Mequon, WI, 53092-4499

    Description

    Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).

    Reason

    The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfunction, Titan Spine, LLC is removing all of the TCS Straight Hex lobular #6 Drivers (5210-1004) Lot# G150101 from the field.

    Action

    Titan Spine sent an "Urgent Medical Device Recall" letter via Fed Ex dated February 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A replacement TCS Straight Hex lobular# 6 Drivers (5210-1004) will be shipped out to each Titan Spine Area Vice President and Sales Rep. within 4-6 weeks. For further questions please call (262) 242-7801.

    Distribution

    US Distribution to the states of : AZ, CA, CT, FL, GA, ID, IL, KY, MD, MO, NV, NY, OH, OK, OR, TX, UT and WI.

    Quantity

    26