| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01211-1 |
| Product Name/Description |
PFN/PFNA Insertion Handle (used for the insertion of Proximal Femur Nail during internal fixation surgery)
Versions 1, 3.1 and 3.2
Part Number: 357.012
Multiple Lot Numbers affected
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a recall for specific lots of Versions 1, 3.1 & 3.2 of the PFN / PFNA Insertion Handle. The PFN/PFNA Insertion Handle is made to insert PFN / PFNA / PFNAII / PFNA augmented nails. The insertion handle may break when struck with a hammer during the nail insertion process. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to inspect stock quarantine affected units for return to JJM.
This action has been closed-out on 07/09/2018. |
| Contact Information |
1300 562 711 - JJM Customer Service |