| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00090-1 |
| Product Name/Description |
Airlight ROM brace (An Orthosis that encompases the knee joint)
Product Code: B-222000000
Batch Number: 091013
Lot Number: 130827
ARTG Number: 135047 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
Australian Orthotic Technologies received notification of failures on a small number of the Ossur Rehab Universal Airlight range of motion knee braces code B-222000000; whereby the braces have broken at the hinge. Customers returned a small quantity (7%) of these braces that had failed under the same circumstance (Locking hinge mechanism breakage) suggesting that there may be a potentially faulty batch. The manufacturer was advised of the issue and affected batch removed from stock.
This action was initiated prior to consultation with the Therapeutic Goods Administration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Australian Orthotic Technologies advised the customers of the locking hinge mechanism failure along with the instructions of how to test product integrity. ATO sales representative visited the customers and completed a swap out of affected batch to new batch.
This action has been closed out on the 09/10/2018. |
| Contact Information |
1300 123 AOT - Australian Orthotic Technologies |