Events

Recall of ATB 35 and ATW 35, Endopath ETS-Flex

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 Endo-Surgery.

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
    2003-12-04
  • 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-agrafeuses-lineaires-coupantes-articulees-atb-35-et-atw-35-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
    In agreement with Afssaps, Ethicon Endo-Surgery is recalling all the batches of the two product codes ATB 35 and ATW 35, Endopath ETS-Flex articulated cutting linear staplers. The attached letter (04/12/2003) (92 KB) was sent on December 3 to the 581 user health establishments, for the attention of the directors of institutions, local correspondents of materiovigilance and pharmacists, for distribution to the care services concerned.

Device

ATB 35 and ATW 35, Endopath ETS-Flex

Manufacturer

Ethicon Endo-Surgery
  • Source
    LAANSM