| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00551-1 |
| Product Name/Description |
3M ESPE Lava Ultimate CAD/CAM Restorative
(Dental mill block)
ARTG Number: 191737 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Approximately 10% of users globally have reported to 3M that Lava Ultimate crowns de-bonded at a rate higher than their typical experience for crowns. The reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature.
Based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016. |
| Contact Information |
02 9498 9333 - 3M |