| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01554-1 |
| Product Name/Description |
O2Vent T
(Mandible-repositioning anti-snoring orthosis)
Catalogue Number: O2VTDL
ARTG Number: 275667 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
1300 533 159 - Oventus |