| TGA Action ID |
RC-2025-RN-01088-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
AQUASIL PUTTY - SOFT and HARD
AQUASIL PUTTY SOFT REG PACK 2X450ML
Article Number: 60578320
Lot Numbers: 2407449110, 2403440087, 2311432656, 2410455771, 2501459563, 2502462422, 2502464285, 2505469779
AQUASIL PUTTY HARD FAST PACK 2X450ML
Article Number: 60578332
Lot Numbers: 2405445155, 2501461092, 2504469709 |
| ARTG Number |
485066 |
| Unique Device Identifier (UDI) |
TBC |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Certain lots of AQUASIL PUTTY – SOFT and HARD may exhibit an extended setting time, which in some cases could exceed 20 minutes.
The primary clinical purpose of the product cannot be fulfilled due to the long setting time of the product. This will most likely result in user dissatisfaction and repeated impression taking.
At present, no health impacts have been reported in relation to this problem. However, in rare circumstances, there is a potential risk that the product could be swallowed or aspirated, cause periodontal inflammation, lead to possible tooth loss, or result in absorption of residual material. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock and quarantine the affected lot numbers to prevent further use.
- Complete the response form and call the sponsor to obtain a return authorisation number for credit/return of the affected stock.
- Return any affected stock with the response form to the sponsor.
This action has been closed out on 31/03/2026 |
| Action Commencement Date |
24/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 55 29 29 - Client Services, Dentsply Sirona |