Events

Recall of 3I OSSEOTITE CERTAIN DENTAL IMPLANTS

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
    74896
  • Event Risk Class
    Class 2
  • Event Number
    Z-2845-2016
  • Event Initiated Date
    2016-08-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148709
  • 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
    Product was incorrectly packaged.
  • Action
    An Urgent Medical Device Removal Notice is being sent to Customers August 12, 2016, notifying them of the packaging of OSSEOTITE Certain Implant (4x11.5mm) in T3 Implant boxes. This recall is specific to Lot No. 2016031461. The material shipped within the box was described as being correct ,but only the box it was shipped in was incorrect. Customers were notified that there are no immediate or long term health consequences. In the notification letter, customers are instructed to complete the Certificate of Acknowledgement, and to return it via email (postmarket@zimmerbiomet.com) if no product is on hand or to return the certificate with product by shipping materials to: Biomet 3i - Post-Market Returns. Replacement product will be sent to customers upon return. Customers were also advised to keep a copy of their Certificate of Acknowledgement. Further questions should be directed to 1-800 443-8166 between the hours of 8:00 AM and 6:00 PM, Monday thru Friday. For further questions, please call 1-800 342-5454.

Device

3I OSSEOTITE CERTAIN DENTAL IMPLANTS
  • Model / Serial
    Model No: IOSS411; Lot No: 2016031461; UDI: (01)00844868007098(17)210401(10)2016031461.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distributions to the states of : CA and FL., and Worldwide to : Colombia, France, Germany, Italy, and Spain.
  • Product Description
    3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
  • 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