BIOMET 3i Endosseous Dental Implant recall
BIOMET 3i Endosseous Dental Implant.
Why was BIOMET 3i Endosseous Dental Implant recalled?
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BIOMET 3i Endosseous Dental Implant.
- Recalling firm
- Biomet 3i, LLC
- 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.
- Recall date
- April 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)