| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00372-1 |
| Product Name/Description |
TFN-ADVANCED Proximal Femoral Nailing System (TFNA)
Multiple lot numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson is initiating a Recall for Product Correction for the DePuy Synthes TFN-ADVANCED Proximal Femoral Nailing System (TFNA). The TFNA System is intended for treatment of proximal femoral fractures.
There is the potential that the TFNA nails received before March 31, 2015 from the affected lots were assembled with a locking mechanism too close to the top of the nail. This problem was due to human error during assembly of the device with the manufacturer and no design changes are required.
Therefore locking mechanism could:
· Prevent the connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the insertion handle, or
· Cause the bottom of the connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
The above may lead to delays in surgery with the potential for complications associated with prolonged anaesthesia. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A workaround is being provided for users via the customer letter. This action has been closed-out on 08/08/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Pty Ltd |