| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00938-1 |
| Product Name/Description |
Retractor for Sciatic Nerve; and Retractor for Sciatic Nerve, long
Part No’s: 03.100.013 and 03.100.014
Multiple lot numbers affected
ARTG Number: 155807 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty. Ltd. (JJM) is issuing a medical device recall of certain lots of the DePuy Synthes Sciatic Nerve Retractors, which are found in the 3.5mm Low Profile Pelvic System. Please note that there is no replacement for these products available at this time.
Micropores may form on the hollow handle of the Sciatic Nerve Retractor during the manufacturing process that are large enough to allow fluids to enter and exit the hollow handle.
Even with diligent reprocessing/sterilization of the Retractor, subsequent patient(s) may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use.
In the event that the liquid and/or discoloration is not identified preoperatively and enters the operative theatre, there is the potential for surgical delay while a replacement or alternate retractor is requested
A surgical delay may also occur. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect stock on hand and to quarantine affected units prior to return to JJM for a replacement or an account credit. This action has been closed-out on 05/09/2016. |
| Contact Information |
1300 562 711 - Customer Service |