Events

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

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Captiva Spine, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61811
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1649-2012
  • 사례 시작날짜
    2011-11-22
  • 사례 출판 날짜
    2012-05-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-11-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109149
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 원인
    Captiva spine is recalling the smartlox cervical plate components 12 & 14 mm drill bits, single barrel variable drill guides, and double barrel fixed drill guides. the components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. there is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime.
  • 조치
    Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

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
    Orthopedic Devices
  • 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
    Captiva Spine, Inc

Manufacturer

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