Events

Recall of Hip endoprostheses

According to Federal Service for Surveillance in Healthcare, this recall involved a device in Russian Federation that was produced by Zimmer GmbH.

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
    02И-2041/16, ФСЗ 2008/01707
  • Date
    2016-10-14
  • Event Date Posted
    2016-10-31
  • Event Country
    Russian Federation
  • Event Source
    FSSH
  • Event Source URL
    http://www.roszdravnadzor.ru/services/unreg
  • Notes / Alerts
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Extra notes in the data
    Manufacturer Recall

Device

Hip endoprostheses

Manufacturer

Zimmer GmbH
  • 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
    FSSH