| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00956-1 |
| Product Name/Description |
Soft-Core Obturators (Warm bonded endodontic obturation system obturator)
Part Number: 972-3025
Lot Number: 051257342
ARTG Number: 179947 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported to the sponsor that the boxes labelled as Part Number 972-3025, which is the size #25 Obturators, actually contain inner packages of size #30 Obturators. Although an inconvenience, the product will function as expected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Return affected lots to Ormco for replacement with unaffected stock. |
| Contact Information |
1800 643 603 - Ormco Customer Care |