Events

Recall of Bard Composix Kugel Wide Oval and Large Disk Wall Repair Implants

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 BARD.

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
    2007-02-06
  • 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-d-implants-de-refection-de-paroi-bard-composix-kugel-large
  • 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    The company BARD has withdrawn from the market on February 2, 07 all the batches between 43AO *** and 43IQ *** of references 0010202 and 0010204 of the medical device called "Bard Composix Kugel Wide Oval and Large Disk Wall Repair Implants" more reports of rupture of the ring. The company has directly notified the recipients of the incriminated lots with the message attached (02/02/2007) (85 KB) validated by the Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Bard Composix Kugel Wide Oval and Large Disk Wall Repair Implants

Manufacturer

BARD