Events

Field Safety Notices about iAssist Validation Tool/SmartTools Knee System

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland 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
    Vk_20170313_04
  • Event Date Posted
    2017-03-20
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20170313_04
  • 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

iAssist Validation Tool/SmartTools Knee System
  • Model / Serial
    20-8011-021-00 | 130542A1;1405941;140146;140146-1;140147;140407A;140407A-1;140407B;140407-B-1;140860;140860-1;141035;150120;B150120;B150711
  • Product Description
    MD: Total knee prosthesis implantation guide-instrument kit
  • 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
    SATP