Medtronic Sofamor Danek, Satellite System Sphere PEEK 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
    44967
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0208-2008
  • 사례 시작날짜
    2007-09-13
  • 사례 출판 날짜
    2007-12-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2009-08-18
  • 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
    Spinal System - Product Code NVR
  • 원인
    Labeling, including indications for use, lack 510 (k) approval.
  • 조치
    On September 12, 2007, the recalling firm's representatives were instructed by electronic mail to remove any manuals in the field and contact surgeons who have evaluated, implanted or been trained to implant the Satellite System and to collect any guides they may have on site. The sales representatives that have accounts where the Satellite product was shipped directly were mailed the information and instructed to hand deliver the 9/13/07, Urgent Device Recall notices to each consignees risk management office. The recall was then expanded on 10/31/2007, to include the surgical manual, the implants and associated instruments. The delivery of the second Urgent Device Recall Notices, dated 10/25/07, were handled in three ways: 1) The letter was delivered to all initial consignees that received satellite products along with a questionnaire (response card) to be completed by the Risk Manager or equivalent administrative function., 2) The letter without the questionnaire was sent directly to target surgeons who are known to have implanted or have been trained to implant Satellite Product 3) a field action confirmation form was sent to Sales Representative with surgeon customers that are receiving the recall communication. The form will be completed by the Sales Representative to confirm the surgeons have received the recall communication and have returned any of the surgical techniques and instruments.

Device

  • 모델명 / 제조번호(시리얼번호)
    ALL LOTS to include: LX58, MA72, MA98, MY48, NB30, NE32
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    Nationwide
  • 제품 설명
    Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only, REF 9000216, Manufactured at: Warsaw, Indiana, USA
  • Manufacturer

Manufacturer

  • 제조사 주소
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
  • Source
    USFDA