Events

AES ankle prostheses 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Transystème SA 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
  • 날짜
    2008-12-29
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/suspension-de-la-commercialisation-des-protheses-de-cheville-aes-par-la-societe-transysteme
  • 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
    In agreement with Afssaps, the company Transforme, informed, on 09/12/08, the users of the AES ankle prostheses of the suspension of the marketing of this device. The users concerned, in France, have received the attached mail (29/12/2008) (28 ko). A survey conducted by Afssaps, intended to evaluate the rate of geodes and their evolution in patients with AES ankle prostheses, is currently underway. The competent European authorities have been informed of this measure by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services. Read auss. Information / recommendation concerning AES ankle prostheses manufactured by Transystème SA and marketed by Biomet France

Device

AES ankle prostheses
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Transystème SA

Manufacturer

Transystème SA
  • Source
    LAANSM