| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00435-1 |
| Product Name/Description |
Aquasil Easy Mix Putty (used for taking impressions of teeth)
Item Number: 678120
Lot Number: 150629
ARTG Number: 108321 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the affected lot of Aquasil Easy Mix Putty may exhibit setting characteristics which are not normal for this product. The affected products may exhibit an extended set time. There is no risk to patients. |
| Recall Action |
Recall |
| Recall Action Instructions |
Dentsply is advising users to return any remaining unaffected stock. This action has been closed-out on 16/02/2017. |
| Contact Information |
03 9538 8202 - Dentsply Australia |