Events

Safety Alert for radial head prosthesis – MoPyC – Head

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

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
    2014-01-22
  • Event Date Posted
    2014-01-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140122c.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: tornier radial head prosthesis – mopyc – head medical device manufacturer, tornier, has issued a field safety notice concerning radial head prosthesis – mopyc – head with the following details: model: small catalogue number: ptr-h18 serial numbers.: 0743amxxx - 5886amxxx - cb2-425/xx - cb2-243/xx - cb2-244/xx - cb2-245/xx - cb2-146/xx according to the manufacturer, complaints were recorded concerning some cases of broken mopyc heads. the manufacturer has identified that some lots, manufactured in limit of tolerances, had a slightly more frequent risk of rupture. the manufacturer advises users to quarantine and return the affected products. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 jan 2014.

Device

radial head prosthesis – MoPyC – Head
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Tornier radial head prosthesis – MoPyC – Head
  • Manufacturer
    Tornier

Manufacturer

Tornier