Events

Recall of THEOS; THEOS HAP

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Prothéos Industries.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2004-04-08
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-tiges-femorales-theos-a-cimenter-et-theos-hap-societe-proteos
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    In agreement with Afssaps, Prothéos Industries on April 5th, 2004 recalled the first-generation femoral stems THEOS to be cemented and THEOS HAP manufactured between 1998 and January 2000. The attached mail (05/04/2004 ) (238 kb) was sent to the local correspondents of materiovigilance and the directors of the health establishments concerned for distribution to the orthopedic surgeons. The other European countries are not concerned by this recall.

Device

THEOS; THEOS HAP

Manufacturer

Prothéos Industries
  • Source
    LAANSM