Events

Recall of Triathlon Distal Capture Assembly

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-00140-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00140-1
  • 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 orthopaedics has received complaints regarding the disassociation of the cross pin from the action triggers of the triathlon distal capture assembly, which could lead to a loose or disassociated action trigger mechanism and/or loose or disassociated cross pin. although using a capture for the distal femoral resection or proximal tibial resection in a triathlon primary total knee arthroplasty is optional, if the surgeon elects to utilize a capture and such disassociation occurs, there exists the potential for the following harms:·complications associated with a delay in surgery of =15 minutes;·revision surgery to retrieve loose component(s);·local inflammatory response;·inflammatory response stryker representatives will contact customers to physically inspect and remove affected units in the field.
  • Action
    A Stryker representative will arrange for all non-conforming components to be removed and a replacement arranged as required. In the event a Stryker Representative is not available to visit your location to perform the inspection, detailed inspection instructions are provided via the Customer Letter. This action has been closed-out on 21/04/2017.

Device

Triathlon Distal Capture Assembly
  • Model / Serial
    Triathlon Distal Capture AssemblyCatalogue Number: 65411723 All lotsInstrument trays that contain the affected device: 65418002-T & SHAPECONV-TARTG number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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