Reported Jul 15, 2015 · Terminated
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC,…
3M Company - Health Care Business
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: 3M Company - Health Care Business · 3M Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN · 55144
Is this the product you have?
- Block Versions Used by Dental Offices
- often referred to as chairside millingLava 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 LaboratoriesLava 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
- Lot codes and dates
- All products in the Lava Ultimate product family.
- Amount recalled
- 1.8 million (US 1,017,834)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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