Events

Field Safety Notices about porous revision hip joint prosthesis zmr and zmr reusable hip joint prosthesis zmr.

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland that was produced by ZIMMER.

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
    2011
  • Date
    2011-11-29
  • Event Country
    Poland
  • Event Source
    ORMPMDBP
  • Event Source URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-porowatej-rewizyjnej-protezy-stawu-biodrowego-zmr-i
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal 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 Poland.
  • Extra notes in the data
  • Action
    ZIMMER safety note on ZMR porous revision hip joint prosthesis and ZMR cone hip reusable hip prosthesis.

Device

porous revision hip joint prosthesis zmr and zmr reusable hip joint prosthesis zmr.
  • Model / Serial
  • Manufacturer
    ZIMMER

Manufacturer

ZIMMER
  • 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
    ORMPMDBP