Events

Field Safety Notices about BellaTek Zirconia Dental Abutment

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Biomet 3i.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    Vk_20130918_28
  • Event Date Posted
    2013-09-23
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20130918_28
  • Notes / Alerts
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Switzerland.
  • Extra notes in the data

Device

BellaTek Zirconia Dental Abutment
  • Model / Serial
    EDAZ, EDAZX | see list
  • Product Description
    MD: Dental implant suprastructure, permanent
  • Manufacturer
    Biomet 3i

Manufacturer

Biomet 3i
  • 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
    SATP