Events

Recall of SEM III titanium femoral prostheses

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 Science et Médecine.

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
    2003-10-09
  • 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-de-lots-de-protheses-femorales-sem-iii-titane-fabriques-entre-1997-et-2001
  • 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
    The company Science et Médecine informed Afssaps on September 17, 2003 that it was recalling batches of SEM III titanium femoral prostheses manufactured between January 1997 and March 2001. The attached letters were sent by the company Science et Médecine to orthopedic surgeons and local correspondents for material vigilance of the 88 health establishments concerned. The references and lot numbers of the recalled devices appear on the list attached to these letters. This file is currently being assessed by Afssaps. The surgeons concerned were directly informed of the progress of the investigations conducted by the Afssaps. Courrier de l'Afssaps (22/10/2003) (52 KB) Courrier de Science et Médecine (15/09/2003 ) (58 KB) Courrier de Science et Médecine (17/09/2003) (74 KB List of batches of devices recalled (21/10/2003) (793 KB)

Device

SEM III titanium femoral prostheses

Manufacturer

Science et Médecine
  • Manufacturer Parent Company (2017)
    Acropole
  • Source
    LAANSM