Device Recall 6hole Pubic Symphysis plate

  • 모델명 / 제조번호(시리얼번호)
    Lot number: 383813
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
  • 제품 설명
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with || 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. || The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • 제조사 모회사 (2017)
  • Source
    USFDA