| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00672-3 |
| Product Name/Description |
Indirect (Closed-Tray) Transfer for Internal Hexagon (Used to create the necessary dental suprastructure preparation during the healing and sculpturing period of the soft tissue)
Part Number: SPMT
Lot Number. 60582680
ARTG Number: 126570 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
The external packaging label product description reads 'COPING, TRANSFER, WAXING' instead of 'Indirect (Closed-Tray) Transfer for Internal Hexagon'. |
| Recall Action |
Recall |
| Recall Action Instructions |
Quarantine and return affected stock to Zimmer |
| Contact Information |
02 9950 5434 - Zimmer Regulatory Affairs |