Device Recall Tritium Sternal Plate System

  • 모델명 / 제조번호(시리얼번호)
    Model: 86-27-12-S12 UDI Number: 00846468061463 LOT: 168952 Expiration:12/23/2018
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of TX and FL
  • 제품 설명
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. || The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. The screws are packaged as a 12 pack using a double tray packaging configuration.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • 제조사 모회사 (2017)
  • Source
    USFDA