Events

CALMABLE Gaines 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 SERF 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
    2008-03-28
  • 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-lot-de-gaines-calcinables-du-systeme-prothetique-multi-references-multi-lab-4-multi-lab-3-3-gtmu-3-3-societe-serf
  • 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 27/03/08, the company SERF removed from the market the batches of the references contained in the attached message of the medical device called CALMABLE Gaines of the prosthetic system MULTI references MULTI LAB 4 - MULTI LAB 3,3 - GTMU 3,3 , manufactured by SERF, following the demonstration of the fragility of certain VMU 1.2 T prosthetic screws packaged with burnout sheaths of the MULTI prosthetic prosthetic system. This fragility can result in the rupture of the screw head of prosthesis during tightening tests carried out on the prosthetic abutments MULTI with a torque lower than the recommended value. The company SERF directly warned the recipients of the incriminated batches with the message attached (27/03/2008) ( 16 kb) validated by Afssaps. The competent European authorities concerned are informed of this measure by the manufacturer.

Device

CALMABLE Gaines
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    SERF

Manufacturer

SERF
  • Source
    LAANSM