| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00664-1 |
| Product Name/Description |
Myobrace for Adults A2 Medium Purple
Batch number: 20170606001
Expiry dates: 06/2027, 06/2029
ARTG 278079
(Myofunctional Research Co - Orthodontic appliance, retainer) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
The labelled expiry date exceeds the intended expiry date (03/2025) on products that have been distributed.
At the time of identification of the incident, the products are within the acceptable shelf life period. Products were labelled with an expiry date of either 06/2027 or 06/2029.
It is possible that the device may deteriorate due to aging after March 2025. This deterioration may be observed as signs of surface cracking, hardening, softening, or tackiness. |
| Recall Action |
Recall |
| Recall Action Instructions |
For devices that have already been used, there is no action required. The product use has commenced within the intended shelf life of the product.
For any unused product remaining in their possession, customers should inspect the stock and quarantine affected units.
Customers should return affected stock on hand via the customer acknowledgement form so MRC can contact them to arrange for replacement of the affected units or provide a credit. |
| Contact Information |
07 5573 5999 - Myofunctional Research Regulatory Affairs contact |