Events

Recall of X3 TRIATHLON INSERT CR#2 9MM

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-2015-RN-00620-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00620-1
  • 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
    A customer complaint identified that a triathlon tibial bearing insert cs x3 size #2 9mm (5531-g-209) was reported to be incorrectly packaged and labelled as a triathalon cr size #2 9mm insert (5530-g-209).Although a delay in surgery of 10 minutes was reported in the complaint, no actual harm was reported.
  • Action
    Users are asked to inspect stock on hand and quarantine any affected units. This action has been closed-out on 05/09/2016.

Device

X3 TRIATHLON INSERT CR#2 9MM
  • Model / Serial
    X3 TRIATHLON INSERT CR#2 9MMCatalogue Number: 5530G209Lot Number: LEF064ARTG Number: 216480
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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