Events

Recall of Hyalskin, Mesoface, Reparestim HA, Biostyle, Zetaderm, Zetavisc, Philoderm Professionnal Mesoface

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 Medical Shock;Sun Communication;Philoderm Aesthetics.

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
    2011-10-18
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/hyalskin-mesoface-reparestim-ha-biostyle-zetaderm-zetavisc-mesoface-philoderm-professionnal-choc-medical-sun-communication-philoderm-aesthetics-retrait-de-produits
  • 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 application of the decision of 03/10/2011, companies SHOCK MEDICAL, SUN COMMUNICATION, PHILODERM AESTHETICS are required to withdraw from the market all batches of medical devices called HYALSKIN, MESOFACE, HA REPARESTIM, BIOSTYLE, ZETADERM, ZETAVISC, MESOFACE PHILODERM PROFESSIONAL. Indeed, the manufacture, placing on the market, distribution, export and use of these products were suspended by decision of the Chief Executive Officer of Afssaps until the products were brought into line with the regulations is 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. This withdrawal follows the withdrawal initiated pursuant to the decision of the Chief Executive Officer of Afssaps of 04/07/2011, repealed by the decision of 03/10/201. . Read auss. Hyalskin, Mesoface, Reparestim, Biostyle, Rofilan Hylan Gel, Philoderm Beauty Gel, Zetaderm, Zetavisc, Esthirase, Philoderm, Professional, Mesoface, Repairs, Refills and Stimulates - Batch Removal. (20/07/2011)

Device

Hyalskin, Mesoface, Reparestim HA, Biostyle, Zetaderm, Zetavisc, Philoderm Professionnal Mesoface

Manufacturer

Medical Shock;Sun Communication;Philoderm Aesthetics
  • Source
    LAANSM