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-01554-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01554-1
  • 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 instructions for use (ifu) in relation to the adjustment range for titration is necessary. the adjustment of the screw and hook allows for appropriate titration by mandibular advancement for optimised treatment. the therapeutic treatment is unaffected by the revised adjustment range for titration. the revised adjustment range is as follows:one full turn using the adjustment key is 360 degrees. this will adjust the pitch of the screw by 0.5mm resulting in a 0.5mm titration. the screw should be adjusted a maximum of 1mm per night (i.E. 2 full turns of the adjustment key).This update only affects some patients who are currently being reviewed for optimised treatment.
  • Action
    Clinicians are advised that if their patient’s treatment has been optimised with the current positioning of their device, this correction does not affect them. They are also advised to provide a copy of the updated Instructions of Use to their patients. This action has been closed-out on 26/05/2017.

Device

O2Vent T(Mandible-repositioning anti-snoring orthosis)
  • Model / Serial
    O2Vent T(Mandible-repositioning anti-snoring orthosis)Catalogue Number: O2VTDLARTG Number: 275667
  • Manufacturer
    Oventus Pty Ltd

Manufacturer

Oventus Pty Ltd