Events

Helianthe Hip Resin Rods 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Wright Medical Technology - EMEA 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
    2008-04-02
  • 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-tiges-de-protheses-de-hanche-helianthe-societe-wright-medical-technology-emea
  • 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 March 31, 2008, Wright Medical Technology - EMEA withdrew from the market the batches of the references contained in the attached medical device message called Helianthe Hip Resin Rods, manufactured by Wright Medical Technology, Inc., continued a non-conformity of the rods to the manufacturing specifications regarding the anteroposterior width (A / P) of the proximal end of the rod. Indeed, these devices are slightly undersized at the thickest point of the proximal width. The company Wright Medical Technology - EMEA has directly notified the recipients of the offending lots with the enclosed message validated ( 02/04/2008) (78 ko) by Afssaps. This information is intended for surgeons for dissemination to the relevant services where applicable. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

Helianthe Hip Resin Rods

Manufacturer

Wright Medical Technology - EMEA