Events

Recall of DVR ePAKs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomet Australia 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-00142-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00142-1
  • 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
    Iron oxidation has been found on components (mainly drill bits) contained in the dvr epaks. a delay in surgery, less than 30 minutes may occur if surgical staff proceeds to re-sterilise the product or locate alternative products. if oxidative material would flake off a component contained within the epak and enter the surgical field/wound, an inflammatory reaction may occur. the inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity.
  • Action
    Zimmer Biomet is advising users to quarantine affected stock for return to Zimmer.

Device

DVR ePAKs
  • Model / Serial
    DVR ePAKsAll lots are affected Multiple Part Numbers affectedARTG Number: 210295
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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