Events

Recall of Gynecare PROLIFT SYSTEM FOR CURE PROLAPSUS TOTAL

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
    2007-05-02
  • 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-d-un-lot-de-gynecare-prolift-systeme-pour-cure-de-prolapsus-total-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 27/04/07, the company ETHICON SAS (Division Women's Health & Urology) withdrew from the market the medical device called Gynecare PROLIFT SYSTEM FOR CURE PROLAPSUS TOTAL lot 2990052 following the detection of a labeling error. The company has directly notified the recipients of the offending lot with the attached message validated by Afssaps (27/04/2007) (73 KB). This information is intended for health facility managers and to local correspondents for material vigilance for dissemination, where appropriate, to the services concerned. The competent European authorities concerned shall be informed of this measure by the company.

Device

Gynecare PROLIFT SYSTEM FOR CURE PROLAPSUS TOTAL
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon