Device Recall LP Rotate Foot System

  • 모델명 / 제조번호(시리얼번호)
    LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland,
  • 제품 설명
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. || -Low profile foot module with adjustable shock absorber and rotation || with progressive stiffening || -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) || with female pyramid adapter 153 165mm (6 - 6 1/2) || -Male pyramid adapter || -Female pyramid adapter || -Maintenance free, no lubrication required || -Maximum weight: 147kg (325lbs) || -Available in sizes 22-30
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • 제조사 모회사 (2017)
  • Source
    USFDA