Events

Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics 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
    25460
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0587-03
  • 사례 시작날짜
    2003-01-07
  • 사례 출판 날짜
    2003-02-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2003-07-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25872
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
  • 원인
    Some components have disassociated post-operatively resulting in additional surgery to the patient.
  • 조치
    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

Device

Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, ste...
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. Lot No. Description  6485-3-000 D6MR MRS SML FEM STEM 10 X 102; 6485-3-011 D6CEB MRS 11MM X 127MM FEMORAL STEM; 6485-3-013 D6CFB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFG MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6CFE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZE MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6GZC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAB MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAC MRS 13MM X 127MM FEMORAL STEM; 6485-3-013 D6HAD MRS 13MM X 127MM FEMORAL STEM; 6485-3-015 D6CHD MRS 15MM X 127MM FEMORAL STEM; 6485-3-017 D6BZC MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPA MRS 17MM X 127MM FEMORAL STEM; 6485-3-017 D6GPD MRS 17MM X 127MM FEMORAL STEM; 6485-3-311 D6CAB MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6CAA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTA MRS 11MM X 203MM FEMORAL STEM; 6485-3-311 D6GTB MRS 11MM X 203MM FEMORAL STEM; 6485-3-313 D6CBC MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBD MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6CBB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWB MRS 13MM X 203MM FEMORAL STEM; 6485-3-313 D6GWC MRS 13MM X 203MM FEMORAL STEM; 6485-3-317 D6GM MRS 17MM X 203MM FEMORAL STEM; 6485-6-409 D6HMA MRS 9MM TIBIAL STEM; 6485-6-411 D5XWB MRS 11MM TIBIAL STEM; 6485-6-411 D6HNA MRS 11MM TIBIAL STEM;
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.
  • 제품 설명
    Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • 제조사 주소
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA