Events

Field Safety Notices about Disposable Coring Trephine and Disposable Dowel Harvest Tube

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Biomet Sports Medicine Inc..

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 Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/docs/default-source/Safety-Notices/fsnsummary_oct2010_qmsversion_final_061110-(2).pdf?sfvrsn=0
  • Notes / Alerts
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
  • Extra notes in the data
    Advice has been provided by the manufacturer regarding a device removal. 3rd Party Publications

Device

Disposable Coring Trephine and Disposable Dowel Harvest Tube
  • Model / Serial
  • Product Description
    Disposable Coring Trephine and Disposable Dowel Harvest Tube
  • Manufacturer
    Biomet Sports Medicine Inc.

Manufacturer

Biomet Sports Medicine Inc.
  • 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