BEUDAMED
    FDA Enforcement Class II 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 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1324-2015
    Event ID
    70576
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TITAN SPINE, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    February 20, 2015
    Classification Date
    March 26, 2015
    Termination Date
    April 17, 2015
    Address
    6140 W Executive Dr, Suite A, Mequon, WI, 53092-4499, United States

    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.

    Code Info

    G150101

    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