Device Recall Mini MaxTorque HCS05632 Drivers

  • 모델명 / 제조번호(시리얼번호)
    HSC-056-38-1067061
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
  • 제품 설명
    OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS || The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Orthohelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina OH 44256
  • 제조사 모회사 (2017)
  • Source
    USFDA