Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Block Versions Used by Dental Offices often referred to as Recalled by 3M Company - Health Care Business Due to 3M is initiating a Field Correction to remove...

Date: June 15, 2015
Company: 3M Company - Health Care Business
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact 3M Company - Health Care Business directly.

Affected Products

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.

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

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About 3M Company - Health Care Business

3M Company - Health Care Business has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report