Events

Recall of AURA II femoral stem bundles

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 Biomet Merck France.

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
    2004-04-30
  • 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-tiges-femorales-aura-ii-de-la-societe-biomet-merck-france
  • 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, Biomet Merck France on April 28, 2004 recalled several batches of femoral stems AURA II. The attached letter (28/04/2004) (192 KB) was sent to the local correspondents of materiovigilance and the directors of the health establishments concerned for distribution to orthopedic surgeons. Other European countries have been informed of this recall by the manufacturer. This information concerns the directors of health establishments and local correspondents of materiovigilance for diffusion to orthopedic surgeons. List of the numbers of the femoral stem range II (28/04/2004) (192 ko)

Device

AURA II femoral stem bundles

Manufacturer

Biomet Merck France
  • Source
    LAANSM