| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00026-1 |
| Product Name/Description |
Extraction Screw for PFNA Blade
Part Number : 356.825
Multiple Lot Numbers affected
ARTG Number: 155807 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
The affected lots of the Extraction Screw could break or disassemble from the instrument. This may interfere with removal of the PFNA and PFNA-II Blade from the patient.
The reported issue could lead to surgical delay and/or adverse tissue reaction. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.
This action has been closed out on 7/09/2018. |
| Contact Information |
1300 562 711 - JJM Customer Service |