| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00198-1 |
| Product Name/Description |
Maxcem Elite (Dental cement)
Multiple part numbers and lot numbers
Product with expiration dates through August 2015
ARTG Number: 175450 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of Kerr Australia that an issue with the raw material used to produce the affected lots of Maxcem Elite causes the material to prematurely polymerise in the syringe. The product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to replacing restorations on the tooth or core build up. As a result, the restoration may not be sealed properly. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kerr Australia is requesting customers to review their stock and to determine if they have any affected lots. Any affected lots have been requested to be returned to Kerr Australia immediately. |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |