Events

Safety Alert for Implants of the Nail System for Ankle Fusion TTC VALOR

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Wright Medical Technology, Inc || Wright Medical Uk Ltd.

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
    I1804-268
  • Event Number
    2016DM-0014732
  • Date
    2018-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=49
  • 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

Device

Implants of the Nail System for Ankle Fusion TTC VALOR
  • Model / Serial
    415101020R / 415101115R, lots 1608296 / 1610957
  • Product Description
    Designed to facilitate tibiotalar arthrodesis in order to treat severe deformities, arthritis, instability and skeletal defects of the foot and ankle after resection of tumors, including neurosin-osteoarthropathy (charcot foot), avascular necrosis of the talus, failure of joint replacement, ankle fusion failure, no joints in distal tibia fractures, osteoarthritis, rheumatoid arthritis, and pseudoarthrosis.
  • Manufacturer
    Wright Medical Technology, Inc || Wright Medical Uk Ltd

Manufacturer

Wright Medical Technology, Inc || Wright Medical Uk Ltd