Events

Recall of Excia Hip Prosthesis

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 AESCULAP ​​AG Co KG.

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
    2007-10-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-prothese-de-hanche-b--braun
  • 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
    On October 3, 2007, the company B. Braun withdrew the lot 51283009 of the reference NC410T - Size 10 of the medical device called Excia Hip Prosthesis, without cement, manufactured by AESCULAP ​​AG Co KG, following an isolated incident of rupture of the stem in England. The company B. Braun directly warned the recipients of the incriminated lot with the message attached (04/10/2007) (92 KB) validated by the Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Excia Hip Prosthesis

Manufacturer

AESCULAP ​​AG Co KG
  • Source
    LAANSM