| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01572-1 |
| Product Name/Description |
O2Vent T
(Mandible-repositioning anti-snoring orthosis)
Catalogue Number: O2VTDL
Devices manufactured & delivered from 17 Nov 2016
ARTG Number: 275667 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1300 533 159 - Oventus |