Events

Recall of PROXIMATE PPH hemorrhoidal circular stapler batch

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
    2008-02-07
  • 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-d-agrafeuse-circulaire-hemorroidaire-proximate-pph-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
    On 06/02/08, the company ETHICON withdrew the lots C4FF4Y; C4FW34; C4G23W; C4FW0M; C4G001; D4G986; C4FW0N; C4G06R; D4GD5R of the PPH03 reference of the medical device called PROXIMATE® PPH Hemorrhoidal Circular Stapler. These batches were put on the market after a first recall in April 2007. This first recall was made following a risk of migration of the glue used to glue the outer shell in the guide system staples , may push the surgeon to prematurely interrupt his action, which would result in the incomplete formation of the staple line. The company ETHICON has directly notified the recipients of the incriminated lots with the message attached (06/02/2008) (33 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

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

Manufacturer

Ethicon