Events

Recall of unkown device

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 N/A.

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
    2007-04-24
  • 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-lots-de-casaques-meches-et-sets-d-arthroscopie-et-d-orthopedie-lohmann-et-rausch
  • 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 Lohmann and Rauscher withdrew from the market on 20/04/07 the batches of the medical devices mentioned in the attached table (20/04/2007) (15 KB) following a non-compliance during the periodic validation of the method of sterilization .. The company directly warned the recipients of the incriminated lots with the message attached (20/04/2007) (23 KB) validated by Afssaps. This reminder only concerns France. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary, to the services concerned.

Device

unkown device
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM