Events

Field Safety Notices about Shelhigh Implantable Devices

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Shelhigh Incorporated.

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 Number
    SN2007(01)
  • Date
    2007-05-10
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/shelhigh-implantable-devices&id=199af825-9782-6eee-9b55-ff00008c97d0
  • 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
  • Reason
    The food & drug administration (fda) issued a formal written request to shelhigh inc. to recall all its medical devices.
  • Action
    Please ensure that all appropriate staff who are involved in the implantation / follow up of patients with this type of device are advised of the issue.    The FDA press releases and further information are available on www.fda.gov.

Device

Shelhigh Implantable Devices

Manufacturer

Shelhigh Incorporated
  • Source
    HPRA