Events

Recall of Plate INTRAMESH T1

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 COUSIN BIOTECH.

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
    2007-06-01
  • 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-de-plaque-intramesh-t1-cousin-biotech
  • 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
    In agreement with Afssaps, on May 30, 2007, the company COUSIN BIOTECH proceeded with the recall of batches of the medical device called Plate INTRAMESH T1 references FBIOT12020, FBIOT12025, FBIOT13030 and FBIOT13050, following the highlighting of a weakness of the implant due to a limit value of the textile raw material, which can lead to embrittlement under severe mechanical stress. The company has directly notified the recipients of the incriminated lots with the message attached (01/06/2007) (27 KB) validated by Afssaps. This information is addressed to the directors of health establishments, local correspondents of materiovigilance and pharmacists for dissemination, where appropriate, to the services concerned. The competent European authorities concerned are informed of this measure by Afssaps.

Device

Plate INTRAMESH T1
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    COUSIN BIOTECH

Manufacturer

COUSIN BIOTECH
  • Source
    LAANSM