| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00639-1 |
| Product Name/Description |
Zimmer NexGen Micro Knee Implants (Femur, Patella, Articular Surface) and Provisionals
Multiple part numbers and component types |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
This matter is a follow up to the Safety Alert issued in March 2012 (RC-2012-RN-00366-3) related to a component compatibility issue with the NexGen Cruciate Retaining (CR) Complete Knee System. Specifically, Zimmer had received complaints where a NexGen CR micro articular surface was used with a CR standard femur, even though the compatibility chart indicates that these combinations are not approved. Since the Safety Alert was issued, Zimmer has monitored the occurrence of non-compatible micro component combinations being implanted. This included the usage of micro femurs and micro patellae, in addition to micro articular surfaces. Although the occurrence has been reduced since the 2012 Safety Alert, it has not been eliminated and therefore Zimmer is initiating a recall to remove the affected devices from the market. Surgeons who have implanted the wrong combinations are provided with this information through a Hazard Alert so that the affected patients can be appropriately managed. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer is asking customers to inspect stock and quarantine any of the affected stock, to be collected by a Zimmer sales representative. Surgeons who have implanted the wrong combinations are provided with the information so that the affected patients can be appropriately managed. For more details, please see http://www.tga.gov.au/safety/alerts-device-nexgen-130731.htm . |
| Contact Information |
1800 803 263 - Zimmer Customer Service |