Prozir zirconia ceramic hip prosthesis heads 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Saint Gobain Desmarquest Advanced Ceramics Company 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
    2001-08-16
  • 사례 국가
  • 사례 출처
    ANSM
  • 사례 출처 URL
  • 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
    WARNING. : You have been the recipient of a first alert message. following the decision of August 10, 200. concerning the suspension of use of certain zirconia ceramic hip prosthesis heads produced by Saint Gobain Advanced Ceramics Desmarquest. This message established a list of manufacturers putting these devices on the market and therefore concerned by this measure. The company Saint Gobain Advanced Ceramics Desmarquest meanwhile has forwarded to the Afssaps a complementary list of 10 manufacturers (see below) having also put on the market ceramic heads zirconia lots TH :. AMM - AESCULAP ​​France - PROCOM NORT'ON - IMPLANT SERVICE - STILL ORTHOPEDICS - ARGOMEDICAL AG - MIL - PROSINTESE - STRATEC MEDICAL SA - BIOMET DEUTSCHLAND GmbH. A complementary decision. , including these 10 manufacturers was therefore taken on August 16, 2001. Each manufacturer quoted above will contact your establishment if it has delivered devices affected by this decision to specify models / references and lots affected by this measured.

Device