Events

Recall of Endobon Xenograft GranulesROX05 Endobon-Xenograft Granules 0.5 mlROX10 Endobon-Xenograft Granules 1 mlROX20 Endobon-Xenograft Granules 2 mlROXLG20 Endobon-Xenograft Granules 2 mlROXLG50 Endobon-Xenograft Granules 5 mlROXLG80 Endobon-Xenograft Granules 8 ml

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-2016-RN-00111-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00111-1
  • 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
    Biomet has initiated this action based on results which indicated cytotoxicity tests were not passed at 36 months (real-time) ageing (grade 4 toxicity).If the affected product is used, there is a remote probability that the patient may experience soft tissue irritation and infection.
  • Action
    Biomet 3i is advising users to inspect stock and quarantine the affected units prior to their return. Biomet 3i will replace the affected units.

Device

Endobon Xenograft GranulesROX05 Endobon-Xenograft Granules 0.5 mlROX10 Endobon-Xenograft Granules...
  • Model / Serial
    Endobon Xenograft GranulesROX05 Endobon-Xenograft Granules 0.5 mlROX10 Endobon-Xenograft Granules 1 mlROX20 Endobon-Xenograft Granules 2 mlROXLG20 Endobon-Xenograft Granules 2 mlROXLG50 Endobon-Xenograft Granules 5 mlROXLG80 Endobon-Xenograft Granules 8 mlMultiple Batch Numbers affectedARTG Number: 171507
  • 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