Events

Recall of Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder

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
    58921
  • Event Risk Class
    Class 3
  • Event Number
    Z-2884-2011
  • Event Initiated Date
    2011-03-14
  • Event Date Posted
    2011-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100641
  • 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
    Definitive Castable Cylinder for Dental Restoration - Product Code NHA
  • Reason
    Biomet 3i, palm beach gardens, fl is recalling the model lpccc2 low profile abutment, non-hexed castable cylinder, lots 2010101036 and 2010101037  exp. 10/2015. package labeling may not correctly describe the package contents. product was distributed in europe only.
  • Action
    Biomet 3i sent a "Medical Device Advisory Notice" letter dated February 17, 2011 to all affected customers. The letter described the problem, instructed customers to returned any unused product and to confirm receipt of the notification. For additional information, please contact Customer Service at 800-342-5454.

Device

Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder
  • Model / Serial
    Model LPCCC2 Lot# 2010101036 and 2010101037.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType;=RCL
  • Product Description
    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i || Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
  • 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