Device Recall Synthes Electric Pen Drive (EPD) System

  • 모델명 / 제조번호(시리얼번호)
    Part Number  05.001.012  Lot Numbers AV18166 AV19044 AV20666
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
  • Manufacturer
  • 1 Event

제조사

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