Events

Field Safety Notices about iAssist Validation Tool/SmartTools Knee System

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was produced by Zimmer CAS.

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
    02442/17
  • Date
    2017-06-26
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/06/2017/02442-17_kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Extra notes in the data

Device

iAssist Validation Tool/SmartTools Knee System
  • Model / Serial
  • Product Description
    Medical instruments for use in humans - bone surgery
  • Manufacturer
    Zimmer CAS

Manufacturer

Zimmer CAS
  • 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
    BAM