Events

Recall of Device Recall BellaTek Zirconia Dental Abutment

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
    66787
  • Event Risk Class
    Class 2
  • Event Number
    Z-1215-2014
  • Event Initiated Date
    2013-08-26
  • Event Date Posted
    2014-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123435
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • Reason
    Reports relating to biomet 3i's bellatek zirconia dental abutment fractures were received.
  • Action
    The firm, BIOMET 3i, sent an "URGENT: Medical Device Removal - BellaTek Zirconia Abutments" letter dated August 2013 via email, facsimile or postal mail to its customers. The letter described the product, problem and actions to be taken. All customers were instructed to check their inventory for the affected product; return the abutments to BIOMET 3i for replacement and full credit; complete and return the attached Recall Return Response Form, and to advise their customers and forward a copy of the Medical Device Removal Notice and the contained recommendations. BIOMET 3i has decided to initiate a design change to mitigate the fracture risk, and consequently, will cease distribution of BellaTek Zirconia Abutments unit l the corrective actions are completed. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.

Device

Device Recall BellaTek Zirconia Dental Abutment
  • Model / Serial
    All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of: Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.
  • Product Description
    Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** || Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
  • 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