Events

BIOLOX alumina heads 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 SGM 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
    2005-07-11
  • 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-de-tetes-en-alumine-biolox-de-la-societe-sgm
  • 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    The SGM company has withdrawn from the market on July 6, 2005 batches 3756, 4233 and 4623 of the medical device called "heads BIOLOX alumina 32 mm medium diameter high diameter" reference SGM 34410 distributed by the companies ASTON Medical, PROCOM, ORSEDIS-SPENCER CRAWFORD , OCEAM and NORD IMPLANT following cases of fractures of these heads. The company has directly notified the recipients of the offending lot with the message attached (11/07/2005) (70 KB) validated and completed by Afssaps. This supplement, written by Afssaps after expert opinion, is a letter of recommendation (11/07/2005) (126 ko) relating to the follow-up of patients. This information is addressed to the directors of health establishments and to the local correspondents of materiovigilance for diffusion, if necessary to the services concerned. This reminder only concerns France.

Device

BIOLOX alumina heads
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    SGM

Manufacturer

SGM
  • Source
    LAANSM