Events

Recall of Trinity Acetabular Shell

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Corin 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-00131-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00131-1
  • 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
    There is potential for abrasion of the sterile barrier pouches of the new packaging system which was introduced in november 2015. if this failure was to occur, it could potentially render the product non-sterile.There have been no product complaints received about this issue to date.
  • Action
    Corin is advising users to return all affected product. Product will be replaced with stock packaged in the previous packaging system.

Device

Trinity Acetabular Shell
  • Model / Serial
    Trinity Acetabular ShellMultiple Part Numbers affectedMultiple Lot Codes affectedARTG Number: 235377
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd