| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00355-1 |
| Product Name/Description |
DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)
Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421R
All lots numbers affected
ARTG 219088
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical Pty Ltd has identified that there is potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin, for all lots of DePuy S-ROM Noiles Rotating Hinge Femur with Pin listed. The outer carton and shrink wrap are intact. The complaint rate for 2010 through 2013 is 0.35%. It is believed that these holes result from repeated shipments of the product in loan kits, over a number of years. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The Operating Room staff/surgeon must be made aware of this potential issue. Prior to implantation, staff must inspect product packaging and if it is identified as having holes in one or both sterile pouches do not use the product and quarantine it. A second set of the DePuy S-ROM Noiles Rotating Hinge Femur with Pin will be sent to each case. S-ROM Noiles Rotating Hinge Femur with Pin devices without packaging breaches may continue to be used to avoid temporarily causing a sudden and complete lack of product availability and the bone loss associated with removing a well-fixed MBT Revision Tibial Tray. This action has been closed-out on 29/01/2016. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |