Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00104-1 |
Product Name/Description |
Tytin – Regular Set, Double Spill 50 and 500 capsules (self activating capsules of dental alloy used as a dental restorative)
Tytin – Regular Set, Double Spill – 500 capsules Part Number: 29949
Tytin – Regular Set, Double Spill – 50 capsules Part Number:29948
Lot Number: 3-1069
ARTG Number: 99936 |
Recall Action Level |
Retail |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
29/01/2014 |
Responsible Entity |
|
Reason/Issue |
It was discovered that the product may set 15 seconds faster than specified in the Directions for Use. This set time discrepancy may cause the product to set before there is an opportunity to place it in the tooth cavity. |
Recall Action |
Recall |
Recall Action Instructions |
Kerr is requesting users return affected stock for replacement or credit. This action has been closed-out on 11/02/2016. |
Contact Information |
1800 643 603 - Kerr Australia Customer Care |