Events

Rappel de Surgical Instruments

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par GEM Universal Industry.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2014-02-05
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/instruments-de-chirurgie-gem-universal-industrie-retrait-de-produit
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    Information for local correspondents of materiovigilance, directors of health facilities, surgery and pharmacy. ANSM has decided to suspend the placing on the market, commissioning, importing, exporting and distributing of these products until they are brought into compliance, as well as stopping the use and withdrawing them. Re-usable surgical instruments from the Titanox range marketed by GEM Universal Industrie. For these medical devices, the company does not have a CE marking file compliant. The users concerned have received the attached mail (05/02/2014) (33 KB). Read auss. Surgical instruments put on the market by the company GEM Universal Industrie: Withdrawal and suspension of placing on the market - Information point (05/02/2014) (0 ko) Animal health decision of 28/01/2014 suspending placing on the market, putting into service, importing, exporting, distributing and using surgical instruments, sterilizers and tensiometers placed on the market by GEM Universal Industries, as well as the withdrawal of these products (05/02/2014) (355 ko)

Device

Surgical Instruments

Manufacturer

GEM Universal Industry