FDA Medical Device Recalls (openFDA)
Biomet 3i, LLC: BIOMET 3i Endosseous Dental Implant.
- Recall number
- Z-1458-2014
- Recalling firm
- Biomet 3i, LLC
- Product
- BIOMET 3i Endosseous Dental Implant.
- Status
- Terminated
- Initiated
- 2013-08-29
- Posted
- 2014-04-15
- Terminated
- 2014-10-17
- Reason
- Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
- Root cause
- Process control
- 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.
- Quantity
- 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, 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.
- Lot, serial or model codes
- Model Number(s): Affected devices catalog names are: BNES310, BNET3210, BNPS6511, BNPS6513, BNPS6585, BNPT6510, BNPT6511, BNPT6513, BNPT6585, BNSS310, BNSS311, BNSS313, BNSS610, BNSS613, BNSS615, BNSS685, BNST3210, BNST3211, BNST3213, BNST3215, BNST3285, BNST611, BNST613, BNST685, BOPS6510, BOPS6511, BOPS6515, BOPS6585, BOPT6510, BOPT6511, BOPT6513, BOPT6585, BOSS310, BOSS311, BOSS313, BOSS315, BOSS611, BOSS613, BOSS685, BOST3210, BOST3211, BOST3213, BOST3215, BOST3285, BOST610, BOST611, BOST613, BOST685, FNT3210, FNT3211, IFNT3210, IFNT3211, IFNT3213, IFNT3215, IFNT3285, IFNT610, IFNT611, IFNT613, IFNT685, IFOSS5611, IFOS5685, IFOS610, IFOS611, IFOS615, IFOSM310, IFOSM311, IFOSM313, IFOSM385, IIOS5610, IIOS5611, INT3210, INT3211, INT3213, INT3215, INT3285, INT610, INT611, INT613, INT685, IOSM311, IOSM313, IOSM315, IOSM385, IOSS610, IOSS613, NIIITP6510, NIIITP6511, NIIITP6513, NIIITP6515, NIIITP6585, NINT3210, NINT3211, NINT3213, NINT3215, NINT610, NINT611, NINT613, NINT685, NIOSM311, NIOSM313, NIOSS610, NT3210, NT3211, OSM310, XIFNT3210, XIFNT3211, XIFNT3213, XIFNT3215, XIFNT3285, XIFN610, XIFNT611, XIFNT613, XIFNT685, XIFOSM310, XIFOSM311, XIFOSM313, XIFOSS610, XIFOSS611, XIIOS6510, XIIOS6511, XIIOS6513, XIITP6510, XIITP6511, XIITP6513. Manufactured dates from November 5, 2012 through August 21, 2013.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28