Events

Recall of 12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-00480-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00480-1
  • 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
    Stryker has become aware that gravity sterilisation parameters provided in the 12 instrument sterilisation reprocessing guide (1000400920 rev d) did not fully consider all worst-case scenarios during validation testing. although, to date there have been no reported events to stryker of infection as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection.
  • Action
    End users are advised to discard any old Instructions for Use (IFU) for 12 Instrument Sterilization Tray(s) that make reference to the gravity steam sterilization method (121oC for 30 minutes). New IFU can be downloaded from www.stryker.com/12instrumenttray

Device

12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)
  • Model / Serial
    12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)Catalogue Number: 0242000012All lots shipped from manufacturer between January 10, 2008 and January 10, 2014 ARTG Number: 140639
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA