Events

Safety Alert Or Field Safety Notices for Zimmer Biomet, specific hip and trauma instruments

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Zimmer GmbH.

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
    Safety alert / Field Safety Notice
  • Date
    2018-02-15
  • Event Date Posted
    2018-02-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/zimmer-biomet-specific-hip-and-trauma-instruments-risk-of-infection
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by zimmer gmbh – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (mda/2018/007).
  • Action
    Quarantine affected devices and obtain replacements from the manufacturer. Refer to the manufacturer’s Field Safety Notice (ref ZFA2017-332) for a full list of affected devices. Report all adverse events involving these devices to Zimmer Biomet and the MHRA or the appropriate Devolved Administration.

Device

Zimmer Biomet, specific hip and trauma instruments

Manufacturer

Zimmer GmbH
  • Manufacturer Address
    Anne-Catherine Morancy Meister Zimmer GmbH Sulzer Allee 8 Winterthur 8404 Switzerland Tel: +41 58 854 82 37
  • 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
    MHRA