Events

Safety Alert for PCHS Modular Endo Head - Sterile

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
    2018-300
  • 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/527037-fda-advisory-no-2018-300-product-recall-of-pchs-modular-endo-head-sterile
  • 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
    All concerned healthcare professionals and establishments are hereby advised by the food and drug administration (fda) regarding the voluntary product recall of specific qc numbers of implant pchs modular endo head - sterile, mdr no. 05178, manufactured by orthopaedic international, inc... to continue reading, download attachment... attachments: fda advisory no. 2018-300.Pdf.

Device

PCHS Modular Endo Head - Sterile

Manufacturer

Orthopaedic International, Inc.