Events

Field Safety Notices about 360 vanguard knee revision system - tibial thickness bolts knee prosthetic devices.

According to Ministero della Salute (Health Ministry), this field safety notices involved a device in Italy that was produced by BIOMET.

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
    6871
  • Date
    2016-09-02
  • Event Country
    Italy
  • Event Source
    MSHM
  • Event Source URL
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=6871
  • Notes / Alerts
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
  • Extra notes in the data
  • Action
    urgent call device. specific lots.

Device

360 vanguard knee revision system - tibial thickness bolts knee prosthetic devices.
  • Model / Serial
  • Product Description
    md
  • Manufacturer
    BIOMET

Manufacturer

BIOMET
  • 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
    MSHM