Events

Recall of Juvéderm®

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 LEADerm.

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
    2005-11-02
  • 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-de-lots-de-juvederm-r-18-24-30-24hv-30hv-et-meso-leaderm
  • 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 LEADerm remembers, on its own initiative, all batches of the medical device called Juvéderm® (18, 24, 30, 24HV, 30HV and Meso) coated with CE marking 0120. The company LEADerm has indeed declared to the Afssaps does not have the technical documentation demonstrating the proof of conformity of the product with the essential requirements of the European Directive 93/42 / EC. The company has directly notified the recipients of the offending batches by means of the enclosed message. (02/11/2005) (75 ko) validated by Afssaps .. The European competent authorities concerned are informed by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate, to the services concerned.

Device

Juvéderm®
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    LEADerm

Manufacturer

LEADerm
  • Source
    LAANSM