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Terminated

BIOMET 3i Endosseous Dental Implant.

FDA Recall Z-1458-2014 · Posted 2014-04-15

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2013-08-29
Date Terminated2014-10-17
Product Quantity34,744

Reason for Recall

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

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea (South), Lebanon, Liechtenstein, Lithuania, Mexico, Netherlands, Poland, Portugal, Paraguay, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, Uruguay, Vietnam and South Africa.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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