BIOMET 3i Endosseous Dental Implant.

FDA device recall Z-1458-2014 · posted 2014-04-15 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.

Action taken

Biomet 3i sent an Urgent Medical Device Notice dated September 9, 2013, to all affected customers. The notice identified the product, problem and actions to be taken. Each customer was instructed to check their respective inventory for the affected product and to return any unused quantities along with the attached Recall Response Form. Biomet 3i will issue replacement product at no charge. For questions or concerns, call Biomet 3i at 1-800-342-5454.

Root cause

Process control

Status

Terminated

Product code

DZE

Quantity affected

34,744

Distribution

Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Germany, Dominican Republic, Spain

Date initiated

2013-08-29

Date posted

2014-04-15

Date terminated

2014-10-17

Location

Palm Beach Gardens, FL