Events

Recall of Device Recall Endoskeleton Locking Bone Screw Assembly

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
    71740
  • Event Risk Class
    Class 2
  • Event Number
    Z-2327-2015
  • Event Initiated Date
    2015-07-20
  • Event Date Posted
    2015-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138899
  • 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
    Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
  • Reason
    Titan spine is recalling specific endoskeleton tcs integrated locking bone screw assembly due to the locking bone screw collars not 'locking'.
  • Action
    Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. The letters described the problem and the product involved in the recall. Advised consignees to complete and return the enclosed response form. For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. Distributors were advised to examine their inventory and quarantine the product. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information.

Device

Device Recall Endoskeleton Locking Bone Screw Assembly
  • Model / Serial
    Lot numbers: V03, V05, V06
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA.
  • Product Description
    Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; || 5302-3516 / 03.5 x 16mm Locking Screws; || 502-3518 / 03.5 x 18mm Locking Screws; || 5302-3814 / 03.8 x 14mm Locking Screws; || 5302-3816 / 03.8 x 16 mm Locking Screws; || 5302-3818 / 03.8 x 18mm Locking Screws.
  • 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