Events

Recall Or Safety Alert for "Ardis Inserter" Model 3256-01, lots 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 62KP, 63HJ, 64EY, 68AX, 71JE and 75LE, manufactured between June 2008 and August 2011, and "Intersomatic System Ardis "

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/A.

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
    Recall / Safety Alert
  • Date
    2013-01-10
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Removal of the "Ardis Insertion" device, Model 3256-01, used for the implantation of the "Ardis PEEK intersomatic spacer", and cessation of the implantation of the spacer due to the possibility of implant rupture

Device

"Ardis Inserter" Model 3256-01, lots 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 62KP, 63HJ, 64EY, ...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI