Field Safety Notices about rHead Radial Head / Uni-Elbow

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Stryker 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
    Field Safety Notice
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    The result of a review of the currently available stryker rhead radial head and uni-elbow data showed that there were no conclusive results further supporting the use of the device. because of this, we decided to withdraw the product from markets worldwide.   healthcare professionals working with patients using the stryker rhead radial head / uni-elbow prosthetic system should continue to monitor such patients in accordance with routine care standards, as no additional harm was detected.



  • Manufacturer Parent Company (2017)
  • Source