Events

Safety Alert for unkown device

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Stryker Ireland Limited || Howmedica Osteonics Crop, Ahora Conocido Como Stryker || Orthopedics || Lisi Medical Orthopaedics.

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 ID
    R1606-249
  • Event Number
    2012DM-0009157
  • Date
    2016-05-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=141
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has detected that the referenced devices do not meet the required sterility assurance levels (sal - stealth assurance level) of 10-6, which may lead to the occurrence of potentially serious adverse events on patients.

Device

unkown device

Manufacturer

Stryker Ireland Limited || Howmedica Osteonics Crop, Ahora Conocido Como Stryker || Orthope...
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA