Events

Recall of Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular 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
    2008-05-14
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/chargeur-endopath-ets-35-mm-agrafeuses-lineaires-coupantes-endopath-ets-35-mm-agrafeuses-lineaires-articulees-coupantes-endopath-ets-flex-35-mm-ethicon-sas
  • 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    On 09/05/2008, the company ETHICON SAS has withdrawn from the market the lots mentioned in annex of the named medical devices. ENDOPATH ETS 35 MM LOADER, references TR35W and TR35W. ENDOPATH ETS 35 MM CUTTING LINEAR STAPLES, reference TSW3. ENDOPATH ETS flex 35MM CUTTING LINEAR STAPLES, reference ATW35. manufactured by Ethicon Endo surgery, following the identification of a component defect involved in the production of the chargers and which may be at the origin of the formation of incomplete staple lines. The company ETHICON SAS has directly notified the recipients of the incriminated lots with the message attached (09/05/2008) (56 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular ...
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon