Events

Recall of O2Vent T (Mandible-repositioning anti-snoring orthosis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Oventus 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-2016-RN-01572-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01572-1
  • 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
    The manufacturer has determined that a correction to the adjuster assembly part of the o2vent t device is necessary and must be returned for rework. the adjuster assembly allows adjustment of the screw and hook for appropriate titration by mandibular advancement for optimised treatment. the performance of the device and risk to patient safety is affected by the faulty adhesion of the adjuster assembly part.
  • Action
    Oventus is advising clinicians to inform the patients that are using the affected product and advise them to stop using the device and arrange for it to be returned to Oventus Manufacturing for rework within 10 days. Also, any remaining devices that are currently in their possession should be also be returned for rework. This action has been closed-out on 01/03/2018.

Device

O2Vent T (Mandible-repositioning anti-snoring orthosis)
  • Model / Serial
    O2Vent T (Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLDevices manufactured & delivered from 17 Nov 2016ARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd