Events

AURA II femoral stem bundles 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Biomet Merck France 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
    2004-04-30
  • 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-tiges-femorales-aura-ii-de-la-societe-biomet-merck-france
  • 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, Biomet Merck France on April 28, 2004 recalled several batches of femoral stems AURA II. The attached letter (28/04/2004) (192 KB) was sent to the local correspondents of materiovigilance and the directors of the health establishments concerned for distribution to orthopedic surgeons. Other European countries have been informed of this recall by the manufacturer. This information concerns the directors of health establishments and local correspondents of materiovigilance for diffusion to orthopedic surgeons. List of the numbers of the femoral stem range II (28/04/2004) (192 ko)

Device

AURA II femoral stem bundles
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Biomet Merck France

Manufacturer

Biomet Merck France
  • Source
    LAANSM