| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01259-1 |
| Product Name/Description |
LSX Files, 25mm (Powered endodontic rasp)
Part Number: 835-4525
Lot Number: 091274190
ARTG Number: 113801 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
17/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
It has come to Ormco's attention that the packages labelled as LSX 25mm Files actually contain 30mm LSX Files. |
| Recall Action |
Recall |
| Recall Action Instructions |
Return affected lots to Ormco for replacement with unaffected stock. |
| Contact Information |
02 8875 8180 - Ormco Regulatory Affairs |