Device Recall IBD Disc Space Distractor

  • 모델명 / 제조번호(시리얼번호)
    Catalog number # IS2346AVS; All lots
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AZ, FL, MA, NY, PA, and TX
  • 제품 설명
    Disc Space Distractor || Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 || Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the distal paddle assembly to a specified height. Once the determined height has been achieved the t-handle can be rotated counter-clockwise retracting the paddles and then removed from the defect site. instrument is not used to sustain or support life. it is intended to be used as a manual surgical instrument during inter body disk replacement to distract the vertebrae to aid in removal of disc space, cartilage, bone and soft tissue.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • 제조사 모회사 (2017)
  • Source
    USFDA