Device Recall Square Nut MR Safe

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 AND US97022.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US (states of AR, CA, CO, CT, FL, IA, IL, LA, MD, ME, MI, MN, MS, NJ, NY, OK, PA, SC, TX, and UT) and country of Switzerland.
  • 제품 설명
    Square Nut MR Safe, Catalog Number 03.311.060. || The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a a rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique.
  • Manufacturer
  • 1 Event

제조사

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