Events

Recall of Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)

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-2016-RN-00910-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00910-1
  • 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 received complaints from customers about the device dissociating or breaking during use. an analysis indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier, potentially resulting in disassociation from the instrument. there is a risk that the handle components, including a dowel pin and a locking pin, may potentially disassociate and fall into the wound intraoperatively, necessitating retrieval. there have been no injuries reported as a result of this issue.
  • Action
    Stryker is advising users to inspect inventory and remove the affected devices from the procedure trays. The trays can continue to be used once the affected items have been removed. The affected devices can be returned to Stryker.

Device

Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)
  • Model / Serial
    Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)Item Number: 6541-4-808All Lot Numbers ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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