| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00976-1 |
| Product Name/Description |
DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)
Part Number: 962004000
Lot Numbers: OSA-149328, OSA-161157, OSA-181610
ARTG Number: 137164 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a device recall of the Charnley Pin Retractor & Handle Set due to the potential for breakage of the small extraction peg away from the pin. Analysis of the pegs from the above affected lots identified the existence of microscopic cracks in the weld region. This could lead to decreased strength and a greater risk of instrument fracture under what would be normally acceptable conditions. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical Pty. Ltd. (JJM) is requesting the affected customer to inspect their inventory and quarantine the affected stock. JJM is making arrangements for a courier pick-up (free of charge) of the affected product and is issuing a credit note. This action has been closed-out on 07/06/2016. |
| Contact Information |
1300 562 711 - JJM Customer Service |