| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00939-1 |
| Product Name/Description |
DePuy S-ROM Noiles Rotating Hinge Femur with Pin
Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421R
Affected lots: 314827, 464645, 438249 & 378650
ARTG number: 219088 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
In March, 2014, Johnson & Johnson Medical Pty. Ltd (JJM) issued Recall for Product Correction letter (TGA Ref.: RC-2014-RN-00355-1) for the S-ROM Noiles Rotating Hinge Femur with Pin devices as the company had identified the 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. The new packaging design is complete and products are available with the new packaging. Therefore, Johnson & Johnson Medical Pty Ltd is recalling the products with the previous packaging from the market. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised not to use the affected inventory. Replacement product with the new packaging will be supplied for the affected stock. This action has been closed-out on 06/06/2016. |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |