Events

Recall of Device Recall Emergence Profile (EP) Healing Abutment

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

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
    47342
  • Event Risk Class
    Class 3
  • Event Number
    Z-1366-2008
  • Event Initiated Date
    2008-02-14
  • Event Date Posted
    2008-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69248
  • 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
    Profile Healing Abutment - Product Code NHA
  • Reason
    Mis-labeling: labeled tha53 device packaging may contain itha53 devices (the itha53 is designed to be used with an internally hexed implant--the tha53 is used with an external hex platform).
  • Action
    Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.

Device

Device Recall Emergence Profile (EP) Healing Abutment
  • Model / Serial
    Lot Number: 770147
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
  • Manufacturer
    Biomet 3i, Inc.

Manufacturer

Biomet 3i, Inc.
  • Manufacturer Address
    Biomet 3i, Inc., 4555 Riverside Drive, Palm Beach Gardens FL 33410
  • 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