Events

Recall of Device Recall BIOMET 3i Endosseous Dental Implant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomet 3i, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67609
  • Event Risk Class
    Class 2
  • Event Number
    Z-1458-2014
  • Event Initiated Date
    2013-08-29
  • Event Date Posted
    2014-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125833
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
  • 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.

Device

Device Recall BIOMET 3i Endosseous Dental Implant
  • Model / Serial
    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 Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    BIOMET 3i Endosseous Dental Implant.
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Manufacturer Address
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA