Device Recall Synthes Radial Head Prosthesis: Trial Radial Head

  • 모델명 / 제조번호(시리얼번호)
    All Lots of Part Numbers: 03.402.018, 03.402.020, 03.402.022, 03.402.024, 03.402.026, 03.402.028, 03.402.218, 03.402.220, 03.402.222, 03.402.224, 03.402.226, 03.402.228, 03.402.418, 03.402.420, 03.402.422, 03.402.424, 03.402.426, 03.402.428, 03.402.618, 03.402.620, 03.402.622, 03.402.624, 03.402.626, and 03.402.628.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI.
  • 제품 설명
    Synthes Radial Head Prosthesis: Trial Radial Head || Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA