Events

Recall of Device Recall OSSEOTITE Certain 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
    58766
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-2012
  • Event Initiated Date
    2010-11-18
  • Event Date Posted
    2011-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100455
  • 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
    The product may contain a manufacturing defect, that if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
  • Action
    The firm sent an Urgent: Medical Device Recall letter, dated November 2010, to notify customers that received the Osseotite Certain Implant (IOSS511) of the problem. The customers were instructed to return the unopened device(s) to Biomet 3i for replacement. If customers notice an issue, they were to contact Customer Service at 1-800-342-5454 for assistance. Customers were to respond via fax and return the implant(s) to BIOMET 3i using the address and incident number provided. Customers with questions or concerns were instructed to contact Mark Mashburn at 561-776-6906.

Device

Device Recall OSSEOTITE Certain Implant
  • Model / Serial
    Lot #910695
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA , BR, JP, TW, CA, Germany, and Guam.
  • Product Description
    ***REF IOSS511***OSSEOTITE Certain Implant 5 x 11.5mm***LOT 910695***Sterile using Radiation***Rx Only***BIOMET 3i Dental Iberica S.L.WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n 08940 Cornella de Llobregat (Barcelona) Spain***Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The Thread form titanium screws (cylindrical dental implants) designed to be placed into mandibular or maxillary jaws in order to affix a dental prosthesis (edentulous or partially edentulous segments) that replaces 1 or more missing teeth.
  • 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