Events

Device Recall Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Sofamor Danek USA 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
    78790
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0352-2018
  • 사례 시작날짜
    2017-12-06
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160465
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • 원인
    Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
  • 조치
    Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following: "If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel within your facility as appropriate, and maintain a copy of this notice in your records. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product."

Device

Device Recall Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device
  • 모델명 / 제조번호(시리얼번호)
    UDI 00643169097254 Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
  • 제품 설명
    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • 제조사 주소
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • 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