Events

Recall of PROXIMATE PPH hemorrhoidal circular stapler

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
    2007-04-10
  • 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-agrafeuse-circulaire-hemorroidaire-de-la-societe-ethicon
  • 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    The company ETHICON has withdrawn from the market on April 4, 2007 the lots specified in the message in the appendix of the medical device called "PROXIMATE PPH hemorrhoidal circular stapler" reference PPH03 following a risk of migration of the glue used to glue the outer shell into the system staple guide, which may cause the surgeon to prematurely interrupt his operation, which would result in the incomplete formation of the staple line. The company has directly notified the recipients of the incriminated lots by means of the enclosed message validated by Afssaps (04/04/2007) (65 KB) This information is addressed to the directors of health establishments and correspondents materiovigilance premises for dissemination, where appropriate, to the departments concerned The competent European authorities concerned shall be informed of this measure by the manufacturer.

Device

PROXIMATE PPH hemorrhoidal circular stapler
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon