Events

Safety Alert for rHead Radial Head and Uni-Elbow System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Stryker GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-10-27
  • Event Date Posted
    2017-10-27
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171027a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: stryker gmbh rhead radial head and uni-elbow system medical device manufacturer, stryker gmbh, has issued a medical device safety alert concerning its rhead radial head and uni-elbow system. according to the manufacturer, the result of a review of the currently available data of the stryker rhead radial head and uni-elbow system was found to be inconclusive to continue supporting the performance of the device. consequently, the manufacturer has decided to remove the product from the global markets. health care professionals that have patients using the stryker rhead radial head / uni-elbow prosthesis system should continue to follow up those patients in accordance with the routine standard of care. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 october 2017.

Device

rHead Radial Head and Uni-Elbow System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Stryker GmbH rHead Radial Head and Uni-Elbow System
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH