Events

Recall of Surgical Instruments

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 GEM Universal Industry.

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
    2014-02-05
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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 / 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
    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