Recall of Triathlon Tibial Alignment Ankle Clamp EM

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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 orthopaedics carried out a recall for product correction in july 2013 (rc-2013-rn-00699-1) due to complaints associated with cracks or fracture of the plastic triathlon tibial alignment ankle clamp (old design). this issue may lead to potential complications during surgery in the event a replacement sterile ankle clamp is required mid-procedure, which may create a delay exceeding 30 minutes in duration.
  • Action
    This action has been closed-out on 05/12/2016.


  • Model / Serial
    Triathlon Tibial Alignment Ankle Clamp EMCatalogue Number: 65412609 Lot Numbers: Lots prior to X9L06Affected Kits: 65418002-T, 65418030-T, TRIAR36PREP-T, WKSHP65418002-T & SHAPECONV-TARTG number: 140892
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source