Events

Recall of TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision knee implantation kits)

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-00207-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-03-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00207-1
  • 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 received reports from the field indicating that the handle detached from the cam of the baseplate impactor/extractor assembly instrument.
  • Action
    Stryker is asking customers to inspect Triathlon consignment instrument kits for affected lot numbers and remove any affected items from the Triathlon instrument kit.

Device

TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision kn...
  • Model / Serial
    TRIATHLON Baseplate Impactor/Extractor (Included in the reusable Triathlon primary or revision knee implantation kits)Catalogue Number: 65414805Multiple lot numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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