Events

Recall of Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm

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
    72000
  • Event Risk Class
    Class 2
  • Event Number
    Z-2760-2015
  • Event Initiated Date
    2015-07-29
  • Event Date Posted
    2015-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139565
  • 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
    Mucc2, non-hexed, castable abutment cylinders, has been labeled and distributed as a mucc1c, hexed, castable abutment cylinders for this one lot only.
  • Action
    Biomet sent a Medical Device Recall Notice dated July 27, 2015, to all their clinicians informing them about the recall and to complete the attached recall return response form and any unused product to be replaced at no charge. Contact information 1-800-342-5454

Device

Device Recall UCLA Abutment Hexed Castable Cylinder 3.4mm
  • Model / Serial
    Model # MUCC1C LOT # 1186054
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution including Italy and Uruguay.
  • Product Description
    UCLA Abutment Hexed Castable Cylinder 3.4mm || Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
  • 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