Events

Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular staplers 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Ethicon 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
    2008-05-14
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/chargeur-endopath-ets-35-mm-agrafeuses-lineaires-coupantes-endopath-ets-35-mm-agrafeuses-lineaires-articulees-coupantes-endopath-ets-flex-35-mm-ethicon-sas
  • 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
    On 09/05/2008, the company ETHICON SAS has withdrawn from the market the lots mentioned in annex of the named medical devices. ENDOPATH ETS 35 MM LOADER, references TR35W and TR35W. ENDOPATH ETS 35 MM CUTTING LINEAR STAPLES, reference TSW3. ENDOPATH ETS flex 35MM CUTTING LINEAR STAPLES, reference ATW35. manufactured by Ethicon Endo surgery, following the identification of a component defect involved in the production of the chargers and which may be at the origin of the formation of incomplete staple lines. The company ETHICON SAS has directly notified the recipients of the incriminated lots with the message attached (09/05/2008) (56 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Endopathic magazine 35mm ets, 35mm endopathic linear staplers, 35mm endopathic stapled articular ...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Ethicon

Manufacturer

Ethicon