Events

Safety Alert for EXACTECH Joints Replacement Prosthesis System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Exactech 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 ID
    I1706-215
  • Event Number
    2012DM-0001331-R1
  • Date
    2017-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • 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 reports that it has updated the surgical technique for the implantation of the hip system, clarifying the proper technique for the use of the calcar planar guide tip, including precautions to avoid fracture of the instrument, leading to a reduction in the probability of presenting adverse events on patients. .

Device

EXACTECH Joints Replacement Prosthesis System
  • Model / Serial
  • Product Description
    Indicated in skeletally mature individuals undergoing primary surgery for joint replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems and for fracture treatment, among others. They are also indicated for review of defective anterior reconstructions, where there is sufficient bone density and soft tissue integrity.
  • Manufacturer
    Exactech Inc

Manufacturer

Exactech Inc