Events

Recall of Device Recall 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 Spine, 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
    73265
  • Event Risk Class
    Class 2
  • Event Number
    Z-1019-2016
  • Event Initiated Date
    2016-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143660
  • 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 spine is initiating a medical device correction regarding the virage oct spinal fixation system by providing additional guidance in the virage oct surgical technique manual.
  • Action
    Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to corporatequality.postmarket@zimmerbiomet.com. Questions or concerns can be directed to Customer Service at 1-866-774-6368

Device

Device Recall Virage OCT Spinal Fixation System
  • Model / Serial
    Surgical Technique Manual L1637 Rev B (2014-06)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) and in the countries of Australia and Germany.
  • Product Description
    Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
  • Manufacturer
    Zimmer Spine, Inc.

Manufacturer

Zimmer Spine, Inc.
  • Manufacturer Address
    Zimmer Spine, Inc., 7375 Bush Lake Rd, Minneapolis MN 55439-2027
  • 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