Events

Recall of Device Recall Endo TCS Driver Straight Hexalobe 6 P/N 52101004,

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
    70576
  • Event Risk Class
    Class 2
  • Event Number
    Z-1324-2015
  • Event Initiated Date
    2015-02-20
  • Event Date Posted
    2015-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134071
  • 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
    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.

Device

Device Recall Endo TCS Driver Straight Hexalobe 6 P/N 52101004,
  • Model / Serial
    G150101
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product 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).
  • 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