Class 2 Device Recall Lava Ultimate

• Date Initiated by Firm: June 15, 2015
• Date Posted: July 08, 2015
• Recall Status: Terminated on April 26, 2016
• Recall Number: Z-2052-2015
• Recall Event ID: 71456
• 510(K)Number: K110131 K122569
• Product Classification: Material, tooth shade, resin - Product Code EBF
• Product: 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.
• Code Information: All products in the Lava Ultimate product family.
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3M Center 2510 Conway Ave , B# 275-5-W-6; Saint Paul MN 55144
• For Additional Information Contact: John Cornwell; 651-733-1110
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EBF and Original Applicant = 3M COMPANY; 510(K)s with Product Code = EBF and Original Applicant = 3M ESPE DENTAL PRODUCTS