| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00799-1 |
| Product Name/Description |
SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part of SIGMA Knee System)
Multiple model numbers affected
All lots manufactured after July 2010
ARTG Numbers: 138289, 98092 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
The compatibility chart on the product label and OR Reference Chart literature/poster indicates that the Size 6 Posterior Stabilized (PS) Femoral Component is compatible with the Size 4 Posterior Stabilized (PS) tibial inserts and Size 4 Stabilized Plus (SP) tibial inserts. The Size 6 PS femoral component is NOT cleared for use with the Size 4 Posterior Stabilized (PS) tibial inserts and Size 4 Stabilized Plus (SP) tibial inserts, and should not be implanted with either of these size 4 insert. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Existing OR Reference Charts on posters should be discarded and replaced with revised OR Reference Charts, which will be supplied to the customers by JJM sales representatives. |
| Contact Information |
1800 252 194 - Johnson & Johnson Customer Service |