Events

Recall of Device Recall Zimmer, Virage OCT Spinal Fixation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Biomet, Inc..

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
    72832
  • Event Risk Class
    Class 2
  • Event Number
    Z-0625-2016
  • Event Initiated Date
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142323
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • Reason
    Zimmer biomet is initiating a recall of the virage occipital eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
  • Action
    Consignees were sent a Zimmer Biomet "Urgent Medical Device Recall" letter dated November 17, 2015. One letter was addressed to Risk Manager and Surgeons and a separate letter was sent to Distributors, Sales Representatives, and Distributor Operations Mangers. The letters described the problem and the product involved in the recall. The letter described the "Risk" and the responsibilities of consignees and requested consignees to quarantine the product. Risk Managers and Surgeons were requested to complete and return the Certificate of Acknowledgment form. Distributors, Sales Representatives, and Distributor Operations Mangers were requested to complete and return the Inventory Return certification Form. For questions consignees can call the customer call center at 1-866-774-6368 between 8:00 am and 5:00 pm EST.

Device

Device Recall Zimmer, Virage OCT Spinal Fixation System
  • Model / Serial
    Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
  • Product Description
    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). || UDI Number 889024328952
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA