| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00475-1 |
| Product Name/Description |
PYRENEES Constrained plate 2 Level 36mm
Catalogue Number: 208-42F36
Lot Number: BJTJ |
| Recall Action Level |
Wholesale |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The affected PYRENEES Constrained plates that were made using the incorrect titanium alloy which can result in greater force required to engage/lock the screw and less force to remove. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo are requesting their customer to return the devices to the manufacturer. |
| Contact Information |
02 9006 1662 - Emergo Group |