BIOMET 3i Endosseous Dental Implant.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Biomet 3i, LLC
- Reason for Recall:
- Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BIOMET 3i Endosseous Dental Implant.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1458-2014
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