Device Recall Modular Foot System

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0964081
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.
  • 제품 설명
    Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. || Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
  • Manufacturer
  • 1 Event

제조사

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