Z-2052-2015 Class II Terminated
Recalled by 3M Company - Health Care Business
— Saint Paul, MN
FDA device recall Z-2052-2015 was initiated by 3M Company - Health Care Business on Jun 15, 2015 and is designated Class II. 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. The recall status is terminated (terminated Apr 26, 2016). Affected quantity: 1.8 million (US 1,017,834).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 15, 2015
- Initiation Date
- Jun 15, 2015
- Termination Date
- Apr 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1.8 million (US 1,017,834)
Product Description
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.
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.
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.
Code Information
All products in the Lava Ultimate product family.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2052-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it.