| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00809-3 |
| Product Name/Description |
TempBond NE (temporary dental cement)
Part Number: 33217 - 5ml Syringe
All lots within shelf life
ARTG Number: 171468 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
9/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Kerr Australia advises that the current Directions for Use for TempBond NE lists a Working Time that is not indicative of the actual performance of the product. More specifically, the current Directions for Use lists the Total Working Time as 90 seconds, while the material actually provides a minimum working time of 60 seconds. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Kerr Australia is providing updated Instructions for Use (IFU) |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |