Events

Recall of Triathlon TS Tibial Augments Sizes 3 and 6

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-2018-RN-00162-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00162-1
  • 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 discovered that the product/lot combinations referenced above may contain the incorrect size implant from what is labelled on the box.The triathlon ts tibial augments are laser marked with lot and catalogue number. although the product packaging for the four lots may not match the product contained within, the laser marked details on the implant would increase the likelihood that the surgeon or surgical staff would recognise that the incorrect implant was contained in the package.The size 3 and 6 triathlon ts tibial augments are also visibly different in size. the tibial augment implant can be compared to the corresponding size tibial augment trial (item number: 5545t301 and 5546t601) which would alert a user to a size mismatch.
  • Action
    Stryker is advising users that patients implanted with the affected products should continue to be followed up as per the normal protocol established with their surgeons.

Device

Triathlon TS Tibial Augments Sizes 3 and 6
  • Model / Serial
    Triathlon TS Tibial Augments Sizes 3 and 6Item Number: 5545A3301, 5546A601Lot Numbers: ER9WA1AARTG Number: 242298(Stryker Australia Pty Ltd - Knee wedge)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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