Events

Recall of Titan Spine Endoskeleton TA Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TITAN SPINE, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63549
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2013
  • Event Initiated Date
    2012-10-19
  • Event Date Posted
    2012-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114191
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Spinal vertebral body replacement device - Product Code MQP
  • Reason
    Titan spine llc, is conducting a recall on the endoskeleton ta vbr products. the labeling accompanying this device contains incorrect indications for use.
  • Action
    Titan sent an Urgent Medical Device Recall letter dated October 19, 2012, to all affected customers. The letter described the problem , the product affected and the corrective measures to be taken. Customers were instructed to review any surgeries that were performed at the L5-51 level with the affected device. Customers were asked to communicate any complications associated with those cases to Titan Spine. Customers with questions should call 1-262-242-7801. For questions regarding this recall call 262-242-7801.

Device

Titan Spine Endoskeleton TA Implant
  • Model / Serial
    Model # / Lot #  2107-0118: A110822, A120907. 2107-0120 : A110812, A110830, A120263, A120909. 2107-0218: A110813. 2107-0220: A110828, A120262, A120305, A120801, A120901.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NV
  • Product 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.
  • Manufacturer
    TITAN SPINE, LLC

Manufacturer

TITAN SPINE, LLC
  • Manufacturer Address
    TITAN SPINE, LLC, 6140 W Executive Dr, Suite A, Mequon WI 53092-4499
  • Manufacturer Parent Company (2017)
    Titan Spine LLC
  • Source
    USFDA