| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00892-1 |
| Product Name/Description |
Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kit, Fracture Adapter Tray Screws and Octane-C Intervertebral fusion devices (intended for Primary and Reverse Total Shoulder joint Arthroplasty) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The device labelling identifies the affected parts as having a ten year shelf life, however the packaging configuration that was used qualifies it as a five year shelf life.
This recall action was not notified to the TGA before it was initiated by Exactech Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Cease sale, use and further distibution of the affected products and return the stock to Exactech Australia. |
| Contact Information |
02 9889 4663 - Exactech Australia |