| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00024-1 |
| Product Name/Description |
TempSpan CMT Dental Cement (used to take dental impressions)
Part numbers: N69CA and N69CS
All lot numbers are affected
ARTG Number: 171468 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Kerr Australia advises that these products may exhibit work time fluctuations and work faster than what the directions for use advises. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kerr Australia has requested that dentists and distributors return all lots of TempSpan CMT, Part numbers N69CA and N69CS. Distributors are requested to ensure that any customer they have supplied the product is identified and notified of the the recall within 48 hours. |
| Contact Information |
1800 643 603 - Kerr Australia Customer Care |