| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00606-1 |
| Product Name/Description |
Tytin Regular Set (Dental amalgam)
Tytin Regular Set, Double Spill - 50 Capsules
Part number: 29948
Lot number: 3-1249
ARTG Number: 99936 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Kerr Corporation has received complaints that the amalgam may set faster than specified in the Directions for Use. This set time discrepancy may cause the product to set before there is an opportunity to place it in the preparation or to complete the carving process. There is a low risk associated with the use of this product in that there would be a possible need to remove the set amalgam from the preparation and repeat the procedure. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately return any of the affected stock to Kerr Australia for replacement with unaffected stock. |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |