Events

ABU PHY - SSABU, IOTA Implant - IOT, THETA - THE Implant, Cylindrical Implant - ALPHA, Cylindrical Implant - PHY, Membrane Implant - TAU 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ethical Medical Implants (EMI) 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    R1711454
  • 날짜
    2017-07-19
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 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
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 조치
    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