Events

Field Safety Notices about Metal heads (Modular Femoral Heads, Protasul® S30, Metasul® heads)

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Zimmer GmbH  (Zimmer Biomet).

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

Device

Metal heads (Modular Femoral Heads, Protasul® S30, Metasul® heads)

Manufacturer

Zimmer GmbH  (Zimmer Biomet)
  • 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
    HPRA