Events

Safety Alert for components for the manufacture of lower limb prostheses

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ossur Americas.

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
    I1507-330
  • Event Number
    2010DM-0005590
  • Date
    2015-07-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • 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 states that it has detected that the female union adapters of other brands, connected to the ossur anklebone pyramid, can cause inadequate installation of the prosthesis, causing failures in the pyramidal connector, due to incompatibility of the geometry in the female joint adapters used. , leading to possible adverse events on the patients.

Device

components for the manufacture of lower limb prostheses
  • Model / Serial
    TALUX, VARI-FLEX, VARI-FLEX XC, RE-FLEX SHOCK, RE- FLEX ROTATE, FLEX-FOOT, ASSURE, BALANCE and FOOT J
  • Product Description
    Employees for the tailor-made elaboration of external lower limb prostheses in different levels of deactivation according to the characteristics of each patient.
  • Manufacturer
    Ossur Americas

Manufacturer

Ossur Americas
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    NIDFSINVIMA