Events

Device Recall Medtronic Navigation 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
    63722
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0441-2013
  • 사례 시작날짜
    2012-11-13
  • 사례 출판 날짜
    2012-11-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114623
  • 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
    Medtronic is recalling certain vertex max drill tubes which are used with the stealthstation system due to a defect related to the internal threading for component set up.
  • 조치
    Medtronic Navigation sent a Urgent Medical Device Recall letter dated November 13 -14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed do not use the Vertex Max Cannulated Drill Tube clinically. Medtronic Navigation will remove the Vertex Max Cannulated Drill Tube. Medtronic Navigation will provide a replacement Vertex.Max Cannulated Drill Tube manufactured from a different lot which was inspected to verify the defect has been corrected. If you have any questions about this notification, please contact a Sales Representative in your area. For further questions please call (720) 890-3200 Ext. 3303 .

Device

Device Recall Medtronic Navigation
  • 모델명 / 제조번호(시리얼번호)
    Lot number 120203.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.
  • 제품 설명
    The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. || .
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • 제조사 주소
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA