Events

Safety Alert for COBRA DISTAL RADIUS FIXATOR

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by Orthopaedic International Inc..

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
  • Event Number
    2017-322
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/479570-fda-advisory-no-2017-322
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, 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 Philippines.
  • Extra notes in the data
  • Reason
    Fda advisory no. 2017-322 termination of the voluntary product recallof cobra distal radius fixator the food and drug administration (fda) informs the public that orthopaedic international inc., the marketing authorization holder (mah), has completed the recall, removal, and destruction of cobra distal radius fixator with lot nos. 1601022 and 1600770 from the philippine market. dissemination of the above information to all concerned is requested. attachments: fda advisory no. 2017-322.Pdf.

Device

COBRA DISTAL RADIUS FIXATOR

Manufacturer

Orthopaedic International Inc.