Events

Device Recall Vertex Max Drill Tube 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Navigation, 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
    57549
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1042-2011
  • 사례 시작날짜
    2010-12-15
  • 사례 출판 날짜
    2011-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96537
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • 원인
    Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
  • 조치
    Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.

Device

Device Recall Vertex Max Drill Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 100721
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.
  • 제품 설명
    Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. || Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

Medtronic Navigation, Inc
  • 제조사 주소
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA