Events

SEM III titanium femoral prostheses 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Science et Médecine 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
    2003-10-09
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-lots-de-protheses-femorales-sem-iii-titane-fabriques-entre-1997-et-2001
  • 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 company Science et Médecine informed Afssaps on September 17, 2003 that it was recalling batches of SEM III titanium femoral prostheses manufactured between January 1997 and March 2001. The attached letters were sent by the company Science et Médecine to orthopedic surgeons and local correspondents for material vigilance of the 88 health establishments concerned. The references and lot numbers of the recalled devices appear on the list attached to these letters. This file is currently being assessed by Afssaps. The surgeons concerned were directly informed of the progress of the investigations conducted by the Afssaps. Courrier de l'Afssaps (22/10/2003) (52 KB) Courrier de Science et Médecine (15/09/2003 ) (58 KB) Courrier de Science et Médecine (17/09/2003) (74 KB List of batches of devices recalled (21/10/2003) (793 KB)

Device

SEM III titanium femoral prostheses
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Science et Médecine

Manufacturer

Science et Médecine
  • 제조사 모회사 (2017)
    Acropole
  • Source
    LAANSM