| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00770-1 |
| Product Name/Description |
Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)
Multiple Lot Numbers and Part Numbers
Shipped between June 2015 and April 2016
ARTG Number: 99818 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
Kerr Australia is recalling certain lots of Herculite Ultra, Herculite XRV, Point 4, and Premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. The particulate is visible to Doctors and should be easy to remove prior to or even after curing. The particulate is unlikely to cause any adverse health consequences. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.
This action has been closed out on 13/11/2018 |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |