Events

Recall of Virage Occipital-Cervical-Thoracic (OCT) Spinal Fixation System - Closure Caps (used to stabilise support or correct alignment of spinal vertebrae)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Zimmer Pty Ltd.

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
    RC-2016-RN-00282-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00282-2
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Zimmer spine has received complaints of closure top loosening. loosening may occur when there is off-axis driver pressure and when the rod is not fully seated prior to application and final tightening of closure top.The most probable risks associated with off-axis tightening of the closure top and final tightening of the closure tops prior to the rod being fully seated in the screw is loosening of the closure tops which may result in a revision surgery.
  • Action
    Zimmer Spine is providing users with additional technique guidance in advance of an updated Surgical Technical Manual for the Virage OCT Spinal Fixation System. Surgeons are advised to adhere to the additional guidance provided with the customer letter to minimise the risk of improper locking of the construct.

Device

Virage Occipital-Cervical-Thoracic (OCT) Spinal Fixation System - Closure Caps (used to stabilise...
  • Model / Serial
    Virage Occipital-Cervical-Thoracic (OCT) Spinal Fixation System - Closure Caps (used to stabilise support or correct alignment of spinal vertebrae)Item Number: 07.01728.001All Lots affectedARTG Number: 111775
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 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
    DHTGA