Device Recall SCORPIO PS TIBIAL TRIAL

  • 모델명 / 제조번호(시리얼번호)
    T72-3-0108M SCORPIO PS TIBIAL TRIAL, SIZE 1, 8 MM T72-3-0110M SCORPIO PS TIBIAL TRIAL, SIZE 1, 10 MM T72-3-0112M SCORPIO PS TIBIAL TRIAL, SIZE 1, 12 MM T72-3-0115M SCORPIO PS TIBIAL TRIAL, SIZE 1, 15 MM T72-3-0118M SCORPIO PS TIBIAL TRIAL, SIZE 1, 18 MM T72-3-0121M SCORPIO PS TIBIAL TRIAL, SIZE 1, 21 MM T72-3-0124M SCORPIO PS TIBIAL TRIAL, SIZE 1, 24 MM T72-3-0308M SCORPIO PS TIBIAL TRIAL, SIZE 3, 8 MM T72-3-0310M SCORPIO PS TIBIAL TRIAL, SIZE 3, 10 MM T72-3-0312M SCORPIO PS TIBIAL TRIAL, SIZE 3, 12 MM T72-3-0315M SCORPIO PS TIBIAL TRIAL, SIZE 3, 15 MM T72-3-0318M SCORPIO PS TIBIAL TRIAL, SIZE 3, 18 MM T72-3-0321M SCORPIO PS TIBIAL TRIAL, SIZE 3, 21 MM T72-3-0324M SCORPIO PS TIBIAL TRIAL, SIZE 3, 24 MM T72-3-0508M SCORPIO PS TIBIAL TRIAL, SIZE 5, 8 MM T72-3-0510M SCORPIO PS TIBIAL TRIAL, SIZE 5, 10 MM T72-3-0512M SCORPIO PS TIBIAL TRIAL, SIZE 5, 12 MM T72-3-0515M SCORPIO PS TIBIAL TRIAL, SIZE 5, 15 MM T72-3-0518M SCORPIO PS TIBIAL TRIAL, SIZE 5, 18 MM T72-3-0521M SCORPIO PS TIBIAL TRIAL, SIZE 5, 21 MM T72-3-0524M SCORPIO PS TIBIAL TRIAL, SIZE 5, 24 MM T72-3-0708M SCORPIO PS TIBIAL TRIAL, SIZE 7, 8 MM T72-3-0710M SCORPIO PS TIBIAL TRIAL, SIZE 7, 10 MM T72-3-0712M SCORPIO PS TIBIAL TRIAL, SIZE 7, 12 MM T72-3-0715M SCORPIO PS TIBIAL TRIAL, SIZE 7, 15 MM T72-3-0718M SCORPIO PS TIBIAL TRIAL, SIZE 7, 18 MM T72-3-0721M SCORPIO PS TIBIAL TRIAL, SIZE 7, 21 MM T72-3-0724M SCORPIO PS TIBIAL TRIAL, SIZE 7, 24 MM T72-3-0908M SCORPIO PS TIBIAL TRIAL, SIZE 9, 8 MM T72-3-0910M SCORPIO PS TIBIAL TRIAL, SIZE 9, 10 MM T72-3-0912M SCORPIO PS TIBIAL TRIAL, SIZE 9, 12 MM T72-3-0915M SCORPIO PS TIBIAL TRIAL, SIZE 9, 15 MM T72-3-0918M SCORPIO PS TIBIAL TRIAL, SIZE 9, 18 MM T72-3-0921M SCORPIO PS TIBIAL TRIAL, SIZE 9, 21 MM T72-3-0924M SCORPIO PS TIBIAL TRIAL, SIZE 9, 24 MM All lots.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
  • 제품 설명
    SCORPIO PS TIBIAL TRIAL, non sterile, made in the USA || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
  • Source
    USFDA