Events

Tibial bases and associated inserts 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 SMITH and NEPHEW 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
    2004-07-01
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-d-embases-tibiales-et-des-inserts-associes-de-la-societe-smith-et-nephew
  • 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
    Afssaps has been informed of a withdrawal of all batches of the references specified in the attached list (18/06/2004) (187 KB), of metal tibial bases and related inserts Genesis Uni made by the company SMITH and NEPHEW June 18, 2004, due to problems of intraoperative snap-fastening of the inserts on the tibial bases reported in the USA. No postoperative complication has been reported to date. The 12 health facilities concerned by this recall in France were warned directly.

Device

Tibial bases and associated inserts
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    SMITH and NEPHEW

Manufacturer

SMITH and NEPHEW
  • Source
    LAANSM