Events

I-CONE (ICC) and HE Dental Implants 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Medical Production 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
    201603252
  • 날짜
    2016-03-02
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/implants-dentaires-i-cone-icc-et-he-medical-production-rappel-de-produit
  • 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
    The ANSM has been informed of the implementation of a product withdrawal carried out by the company MEDICAL PRODUCTION .. The users concerned have received the attached mail (02/03/2016) (103 KB). This safety action is registered with the ANSM under the number 201603252. You will be able to consult its progress status on the Directory of materiovigilance reports by entering this registration number. Read too. Decision of 11/02/2016 suspending the manufacture, placing on the market, export, distribution and use of dental implants of the references ICC (I-CONNE) and HE put on the market by the company MEDICAL PRODUCTION as well as withdrawal of these products (16/02/2016) (676 ko)

Device

I-CONE (ICC) and HE Dental Implants
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Medical Production

Manufacturer

Medical Production