| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00284-1 |
| Product Name/Description |
Pulp Canal Sealer EWT Standard, Pulp Canal Sealer EWT Bulk Powder Refill (Root canal sealing material)
Product codes: 24746 and 24745
Lot number: 1-2333
ARTG: 120315 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Complaints were received stating that the Pulp Canal Sealer EWT Standard product was setting too quickly. Investigation has determined that the affected material does indeed set 3 hours faster than specified in the Directions for Use which provide for a work/set time of 6 hours or greater. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are requested to return any affected stock to Ormco Pty Ltd. Replacement stock will be provided. |
| Contact Information |
1800 052 030 - Ormco Customer Care |