3M Company - Health Care Business: Medical Device Recall in 2015 - (Recall #: Z-2052-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 15, 2015

Date Posted: July 15, 2015

Recall Number: Z-2052-2015

Event ID: 71456

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.

Status: Terminated

Product Quantity: 1.8 million (US 1,017,834)

Code Information:

All products in the Lava Ultimate product family.

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.

Voluntary or Mandated:

Voluntary: Firm initiated