Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

FDA Recall Z-2052-2015 · Posted 2015-07-08

Recalling Firm3M Company - Health Care Business
Recall StatusTerminated
Product CodeEBF
Date Initiated2015-06-15
Date Terminated2016-04-26
Product Quantity1.8 million (US 1,017,834)

Reason for Recall

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.

Firm Action

3M ESPE Dental sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June12, 2015 to affected customers. The letter described the affected product, problem and action to be taken. The letter instructed customers to complete and return the Acknowledgement Return/ Refund Form. For questions call 3M ESPE Dental Customer Care center at 1-800-634-2249.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122569LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR3M Company · 2012-09-12K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE3M Espe Dental Products · 2011-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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