Events

Recall of Trident Tritanium Acetabular Window Trials Case

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-2013-RN-01356-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01356-1
  • 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 some outer trays of the trident tritanium acetabular window trials case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray.
  • Action
    Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product.

Device

Trident Tritanium Acetabular Window Trials Case
  • Model / Serial
    Trident Tritanium Acetabular Window Trials CaseCatalogue Number: 24024020Lot Number: 032173ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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