Events

Recall of Universal Clamp System and UniWallis System (used during spinal cord surgery)

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-00232-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00232-1
  • 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 is initiating a recall for product correction to provide updated cleaning, disinfection and sterilisation instruction for use of universal clamp system (ifu, reference: sn2027-n-90001 and uniwallis system (ifu, references: 038wnan0000t). since the market launch of each products (universal clamp system and uniwallis system), the instruments were distributed with instruction for use related to the method for cleaning, disinfection and for steam sterilisation at health care facilities. however, the method was not adequately validated. instruments cleaned, disinfected, and sterilised under the former ifu for the universal clamp and/or uniwallis systems may not be sterile which can result in infection.
  • Action
    Zimmer is providing users with revised Instructions for Use and advising users to discard the previous IFU.

Device

Universal Clamp System and UniWallis System (used during spinal cord surgery)
  • Model / Serial
    Universal Clamp System and UniWallis System (used during spinal cord surgery)All lot numbers affectedARTG Number:157602
  • 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