Devices

Device Recall PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices

  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
  • 제품 설명
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) || Used during primary total knee arthroplasty to improve patient mobility.
  • Manufacturer
    DePuy Orthopaedics, Inc.
  • 1 Event

제조사

DePuy Orthopaedics, Inc.
  • 제조사 주소
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA