Events

Recall of Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expiration dates between November 2015 and November 2020.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomet 3i 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-2015-RN-01208-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01208-1
  • 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
    An investigation has determined that a limited number of product pouches may not have been sealed during packaging (occurrence rate 0.008%). in the event that a product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and may lead to infections or the product may be missing.
  • Action
    The sponsor is advising users to inspect stock and quarantine units from the affected lots regardless of whether a packaging seal can be visualised prior to their return to the sponsor. This action has been closed-out on 29/08/2016.

Device

Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expir...
  • Model / Serial
    Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expiration dates between November 2015 and November 2020.ARTG: 120288
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i 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