BEUDAMED
    FDA Enforcement Class II Terminated

    Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.

    Recall: Z-0535-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0535-2013
    Event ID
    63549
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TITAN SPINE, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    December 26, 2012
    Initiation Date
    October 19, 2012
    Classification Date
    December 17, 2012
    Termination Date
    January 14, 2013
    Address
    6140 W Executive Dr, Suite A, Mequon, WI, 53092-4499, United States

    Description

    Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.

    Reason

    Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

    Code Info

    Model # / Lot # 2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.

    Distribution

    Nationwide Distribution including NV

    Quantity

    92 pcs.