Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compa

FDA device recall Z-2052-2015 · posted 2015-07-08 · Terminated

Recall details

Recalling firm

3M Company - Health Care Business

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

EBF

Quantity affected

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, Lat

Date initiated

2015-06-15

Date posted

2015-07-08

Date terminated

2016-04-26

Location

Saint Paul, MN

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