| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00757-1 |
| Product Name/Description |
TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D
Batch Number: 14CM03676
Model Number: 71675206
ARTG Number: 104370 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a manufacturing error which results in the proximal lag screw being positioned incorrectly. In the event an incorrectly positioned proximal lag screw hole inhibits drilling and causes the user to hit the nail, the following issues could occur: the nail is removed and/or the procedure is delayed, the nail’s fatigue life is reduced, causing the nail to fail within a short period of time. |
| Recall Action |
Recall |
| Recall Action Instructions |
The affected customer has been requested to inspect their inventory and quarantine the affected stock. The local Smith & Nephew Surgical representative will contact the customer to arrange for the product to be returned. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical |