FDAClass IIJuly 15, 2015

Block Versions Used by Dental Offices often recall

Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x…

Why was Block Versions Used by Dental Offices often recalled?

3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All products in the Lava Ultimate product family.

Product
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x…
Recalling firm
3M Company - Health Care Business
Quantity
1.8 million (US 1,017,834)
Distribution
Worldwide Distribution - US: Nationwide and the countries of: Australia, India, Japan, Korea, New Zealand, Singapore, Thailand, Vietnam, Canada, Bulgaria, Czech Republic, Estonia, Hungary, Israel, Latvia, Lithuania, Poland, Romania, Slovakia, Switzerland, Turkey, China Hong Kong, Taiwan, Brazil, Colombia, Costa Rica, Guatemala, Mexico, Egypt, Morocco, South Africa, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Netherlands Norway, Portugal, Spain, Sweden, UK and Ireland.
Recall date
July 15, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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