Device Recall Zodiac Pedicle Screw System

  • 모델명 / 제조번호(시리얼번호)
    Lot # 634745
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including TN, WI, and FL.
  • 제품 설명
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. || Subsequent Product Codes: MNH, MNI. || The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
  • Source
    USFDA