Events

Recall of Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier 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-2014-RN-00973-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00973-1
  • 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
    Tornier sas has identified that some reversed cut guides have been incorrectly assembled during the manufacturing process. a faulty guide will generate an incorrect version measurement and may cause confusion or an improper humeral head resection. all the parts affected come from the same lot number (dp0213287).
  • Action
    Tornier Pty Ltd have all the affected products within their warehouses or their distributors warehouses. Tornier is checking the stock or requesting the distributors to check the stock and if faulty guides are identified, will replace the faulty guides with new ones. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)
  • Model / Serial
    Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)Item Number: MWF011Lot Number: DP0213287ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd