Events

Recall of Hyalskin, Mesoface, Reparestim, Biostyle, Rofilan Hylan Gel, Philoderm Beauty Gel, Zetaderm, Zetavisc, Esthirase, Philoderm, Professional, Mesoface, Repairs, Refills and Stimulates

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 Choc Medical;Sun Communication;Philoderm Aesthetics;Aesthetics Dermal.

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
    2011-07-20
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/hyalskin-mesoface-reparestim-biostyle-rofilan-hylan-gel-philoderm-beauty-gel-zetaderm-zetavisc-esthirase-philoderm-professional-mesoface-repairs-refills-et-stimulates-retrait-de-lots
  • 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
    Following the animal health decision of 04 July 2011 (01/01/1970) (0 KB), Choc Medical, Sun Communication, Philoderm Aesthetics and Aesthetics Dermal are required to withdraw from the market all lots of medical devices called Hyalskin , Mesoface, Reparestim, Biostyle, Rofilan Hylan Gel, Philoderm Beauty Gel, Zetaderm, Zetavisc, Esthirase, Philoderm, Professional, Mesoface, Repairs, Refills and Stimulates. Indeed, the manufacture, placing on the market, the distribution, the export and the use of these products were suspended by decision of the Director General of Afssaps of July 04, 2011, until the products to the regulations applicable to them. The companies have directly notified the recipients of the offending lots. The competent European authorities concerned are informed of this measure by Afssaps. Given the small number of recipients, they are notified directly by the laboratories. No alert number has been assigned to these withdrawals. Read auss. Hyalskin, Mesoface, Reparestim HA, Biostyle, Zetaderm, Zetavisc, Philoderm Professionnal Mesoface - Medical Shock, Sun Communication, Philoderm Aesthetics - Product Withdrawal. (18/10/2011) Decision of 03 October 2011 withdrawing and suspending the manufacture, placing on the market, distribution, export and use of wrinkle treatment and filling products, skin depressions and restoration volumes manufactured by the company CHOC MEDICAL and marketed by the company CHOC MEDICAL under the brands Hyalskin®, Mesoface® and Reparestim HA®, by the company SUN COMMUNICATION under the brand Biostyle®, by the PHILODERM AESTHETICS under the trademarks Zetaderm®, Zetavisc® and Mesoface Philoderm Professional®, and repealing the decision of 04 July 2011

Device

Hyalskin, Mesoface, Reparestim, Biostyle, Rofilan Hylan Gel, Philoderm Beauty Gel, Zetaderm, Zeta...

Manufacturer

Choc Medical;Sun Communication;Philoderm Aesthetics;Aesthetics Dermal
  • Source
    LAANSM