Events

Recall of Arthro-Knife

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 ConMed Linvatec.

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
    2009-08-21
  • 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-des-dispositifs-medicaux-arthro-knife-conmed-linvatec
  • 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 20/08/2009, the company withdrew from the market the batches listed in the appendix of the recall, medical devices called: Arthro-Knife, manufactured by ConMed Linvatec and distributed by ConMed Linvatec. Indeed, as a result of claims in the Netherlands and Japan, the laboratory has shown that the device does not fully retract after deployment. This malfunction can lead to a risk of injury to the user or the patient. The company ConMed Linvatec directly warned the recipients of the incriminated lots with the message attached (21/08/2009) (39 KB) validated by Afssaps.This information is addressed to directors and correspondents of materiovigilance for dissemination where appropriate to the services concerned. The relevant European Competent Authorities have been informed of this measure by the manufacturer.

Device

Arthro-Knife
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    ConMed Linvatec

Manufacturer

ConMed Linvatec