Device Recall Drill Bits for Cervical Plate System

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 89427-2 R & 89427-3-R
  • 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 CP40012***12mm Drill Bit***Lot Number 89427-2 R***" || "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" || 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