Device Recall Medtronic 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 TYRX 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
    74672
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2539-2016
  • 사례 시작날짜
    2016-06-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-12-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • 원인
    Tryx products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
  • 조치
    Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter identified the affected product problem and actions to be taken. Customers are asked to immediately remove and quarantine all unused product that remains in inventory, return unused product to Medtronic and contacted the local Medtronic representative or Customer Service at 800-848-9300 to assist with the return and credit of unused product. Medtronic will provide credit for all non-expired, unused product. The customer should complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.

Device

  • 모델명 / 제조번호(시리얼번호)
    model number  CMRM3122  lot number   15F30614 15F30614-A 15H10630 15K29659 16B05695  model number CMRM3133  lot number   15F18607 15G14620 15J29647 16C03706
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    TRYX Antibacterial Envelope Rx Only || Product Usage: || Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
  • Manufacturer

Manufacturer

  • 제조사 주소
    TYRX Inc., 1 Deerpark Dr Ste G, Monmouth Junction NJ 08852-1920
  • 제조사 모회사 (2017)
  • 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