Events

Safety Alert for Osteosynthesis material

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda.

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
    R1708-354
  • Event Number
    2014DM-0002409-R1 ; 2014DM-0002401-R1 ; 2009DM-0005041
  • Date
    2017-10-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=67
  • 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
    Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed and implemented without meeting the full requirements of the technical and legal provisions that regulate it, for which the product was withdrawn from the market in a preventive manner, as it is considered a fraudulent product.

Device

Osteosynthesis material
  • Model / Serial
  • Product Description
    MDT / BIOTECHNOLOGY joint replacement prostheses are indicated for joint replacement procedures of the shoulder, knee and hip, whether total, partial, modular or revision. Their purpose is to replace the osseous and joint stabilization components for joint function reconstruction in patients with joint damage as a result of pathologies, among others: -non-inflammatory degenerative joint disease (osteoarthritis), -vascular necrosis, -osteoarthritis secondary to trauma, -sequences of trauma, -anquilosis-surgical arthrodesis.
  • Manufacturer
    Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda

Manufacturer

Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Impor...
  • Source
    NIDFSINVIMA