O2Vent T(Mandible-repositioning anti-snoring orthosis) 의 리콜

Recall

RC-2016-RN-01554-1

Class II

2016-12-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01554-1

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.

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.