Events

Recall of E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude 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-2017-RN-00859-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00859-1
  • 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
    In december 2016, a recall action was undertaken (rc-2016-rn-01625-1) following customer complaints about the e.To.I.L.E extension table regarding abnormal wear in the locking system of the external rotation. at this time, the manufacturer, amplitude were to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.An additional analysis of the e.To.I.L.E extension table has been performed and concludes that a design modification of the locking system is recommended to reduce the risk of lack of locking in external rotation. therefore, amplitude has decided to exchange all the e.T.O.I.L.E systems on the market for systems manufactured according to a new design.
  • Action
    As a precautionary measure, Amplitude has decided to exchange all the E.T.O.I.L.E systems on the market by systems manufactured according to new design.

Device

E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)
  • Model / Serial
    E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)Reference Number: 3-0499902Serial Numbers: 159722, 159724, 167258, 169723 and 169979ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd