Events

Recall of Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut)

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-01019-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01019-1
  • 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 customer complaints regarding the triathlon mis modular distal capture device disassociating during use. this may result in one or more of the following potential patient harms: · complications associated with extended surgery time· inflammation / inflammatory response.· revision surgery to retrieve loose spring.
  • Action
    Stryker is advising users to inspect stock and quarantine any affected units. Affected units will be replaced with unaffected stock. This action has beem closed-out on 05/12/2016.

Device

Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection...
  • Model / Serial
    Triathlon MIS Modular Distal Capture (optional tool which can be attached to the distal resection guide to complete the cut)Part Number: 6541-5-723Lot Numbers: AF1C11, AF1C11M, AF1E01D, AF1E01MX3, AF1T43, AF8V03ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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