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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 3M Australia Pty Ltd
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