Events

Recall of Morcellex Tissue Morcators (Surgery)

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
  • Event ID
    201410618
  • Date
    2014-08-18
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/morcellateurs-de-tissus-morcellex-chirurgie-ethicon-rappel-de-produit
  • 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 ANSM has been informed of the implementation of an action of a recall made by the company ETHICON. The users and health professionals concerned received the attached mail (18/08/2014) (65 KB). As a reminder, the ANSM published recommendations on laparoscopic morcellation for the surgical removal of uterine fibroids, following Ethicon's dispatch of an initial information indicating the suspension of marketing of their morcellation products in the month of March. May 2014. Morcellement by laparoscopy for surgical removal of uterine fibroids: ANSM recommendations - Informatio Point. (21/05/2014) Ethicon security note of 14/05/2014 (20/05/2014) (56 KB) This security action is registered with the ANSM under the number 201410618 .. You will have the possibility of consulting its progress on the Directory of the reports of materiovigilance by entering this n ° of registration.

Device

Morcellex Tissue Morcators (Surgery)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon