Device Recall Reverse Shoulder Prosthesis device components 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    37874
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1246-2007
  • 사례 시작날짜
    2007-03-22
  • 사례 출판 날짜
    2007-09-25
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-03-27
  • 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
    Prosthesis device components - Product Code KWS
  • 원인
    Marketed without approval: investigational devices were implanted during an ide study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the ide study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
  • 조치
    Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.

Device

  • 모델명 / 제조번호(시리얼번호)
    0700-031.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
  • 제품 설명
    Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA