Events

Recall of Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2014-RN-00154-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00154-1
  • 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
    Device technologies australia has become aware that the packaging of the cup removal instruments may not provide a sufficient safety barrier when handling and transporting instruments.
  • Action
    The distributors are advised to identify and isolate affected product from use, making sure to handle carefully. A Device Technologies Australia Pty Ltd's representative will contact the distributor to organise a time to repackage affected stock at their site. This re-packaging will consist of: ? Adding a new black cap to the blade ? Wrapping the blade head in bubble wrap and securing with tape. ? Re-packaging in the original packaging ? Addition of a warning sticker ? Addition of compliant labelling

Device

Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minim...
  • Model / Serial
    Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)Multiple Product Codes
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd