Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

  • 모델명 / 제조번호(시리얼번호)
    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including PA, CT, DE, and NY.
  • 제품 설명
    Synthes CMF Distraction System || The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
  • Manufacturer
  • 1 Event

제조사

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