Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS)

  • 모델명 / 제조번호(시리얼번호)
    Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
  • 제품 설명
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. || The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
  • Manufacturer
  • 1 Event

제조사

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