Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System.

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1500705A, 06110041, 1500707A, 06110043, 1500708A, and 06110044
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
  • 제품 설명
    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: || "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" || "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" || "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" || Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. || The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • 제조사 모회사 (2017)
  • Source
    USFDA