Events

Recall of Linear endoscopic staplers

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 Ethicon.

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
    2004-11-25
  • 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-d-agrafeuses-lineaires-endoscopiques-ethicon-endo-surgery
  • 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 November 24, 2004, Ethicon Endo-Surgery withdrew from the market the batches and references contained in the attachment (24/11/2004) (32 KB) of the medical device called linear endoscopic staplers following the increase in claims In cases of incomplete stapling line formation that could lead to a poor restoration of stapled fabric functionality. The company has directly notified the users of the batches concerned by this recall using the attached message (24). / 11/2004) (32 KB) validated by Afssaps. This information is addressed to wardens and local correspondents of materiovigilance. The competent European authorities concerned are informed of this measure by the company. Message Ethico Endo-Surgery (24/11/2004) (32 ko)

Device

Linear endoscopic staplers
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon