| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01002-1 |
| Product Name/Description |
TempSpan CMT (Temporary composite dental cement)
Part Number: N69CA
All lot numbers are affected
ARTG Number: 171468 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The current Directions for Use for TempSpan CMT lists a Working Time that is not indicative of the actual performance of the product. The current Directions for Use lists the Total Working Time as 60 seconds, whereas the minimum working time is 45 seconds. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updating the directions for use. |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |