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.
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The Afssaps was informed on 07/06/2010 of a withdrawal of a lot of femoral stems EXCEPTION® made by the company BIOMET. The users concerned, in France, have received the attached mail (10/06/2010) (20 KB). The competent European authorities have been informed of this measure by manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.