Events

Recall of ABU PHY - SSABU, IOTA Implant - IOT, THETA - THE Implant, Cylindrical Implant - ALPHA, Cylindrical Implant - PHY, Membrane Implant - TAU

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 Ethical Medical Implants (EMI).

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
  • Event ID
    R1711454
  • Date
    2017-07-19
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/implant-dentaire-abu-phy-ssabu-implant-iota-iot-implant-theta-the-implant-cylindrique-alpha-implant-cylindrique-phy-implant-membrane-tau-ethical-medical-implants-emi-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
    ANSM has been informed of the implementation of a withdrawal of product by the company ETHICAL MEDICAL IMPLANTS (EMI). The affected users have received the attached mail. (19/07/2017) (125 KB) This safety action is registered with the ANSM under the number R1711454 Read also Decision of 20/06/2017 suspending manufacture, placing on the market, export , distribution and use of medical devices for dental implantology marketed by the company ETHICAL MEDICAL IMPLANTS (EMI) and manufactured from the reference raw material VESTAKEEP 4000P, as well as the removal of these products (29 / 06/2017) (1509 KB)

Device

ABU PHY - SSABU, IOTA Implant - IOT, THETA - THE Implant, Cylindrical Implant - ALPHA, Cylindrica...

Manufacturer

Ethical Medical Implants (EMI)
  • Source
    LAANSM