Events

Birmingham HIP Total Modular Head Hip Prosthesis;Birmingham HIP Modular Head (BHMH) 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Smith & Nephew 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
  • 사례 ID
    201503987
  • 날짜
    2015-04-02
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/chirurgie-orthopedique-prothese-totale-de-hanche-a-tete-modulaire-birmingham-hip-birmingham-hip-modular-head-bhmh-smith-nephew-information-de-securite
  • 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
    ANSM has been informed of the implementation of a safety action carried out by Smith & Nephew. The affected users have received the attached mail (02/04/2015) (119 KB). The ANSM reminds users of metal-to-metal friction hip prostheses that a warning to orthopedic surgeons and follow-up recommendations for patients carrying these implants have been published on its website. Risks related to metal-to-metal friction torque hip prostheses: Recommendations for use and monitoring of patients - Informatio Point. (17/12/2014) This safety action is registered with the ANSM under the number 201503987 .. You will be able to consult its progress report on the Directory of the signaling of materialovigilanc by entering this n ° of recording.

Device

Birmingham HIP Total Modular Head Hip Prosthesis;Birmingham HIP Modular Head (BHMH)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew