Events

Device Recall ChordX Chordal Sizer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 On-X Life Technologies, 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
    75951
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1057-2017
  • 사례 시작날짜
    2016-12-13
  • 사례 출판 날짜
    2017-01-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151822
  • 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
    Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replac - Product Code PAW
  • 원인
    Four issues were uncovered by the recalling firm's capa: 1) burrs were found to be present on left housing, right housing and barrel components, 2) loose plastic particulate was found within sealed primary packages, 3) loose hair was discovered within four sealed primary packages and 4) assembly error, wherein left and right housing components were acceptably press-fit together, was discovered within one sealed primary package. one of the left housing press-fit pins was not pressed into the associated hole of the right housing, resulting in a small gap in the housing assembly.
  • 조치
    A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.

Device

Device Recall ChordX Chordal Sizer
  • 모델명 / 제조번호(시리얼번호)
    72-00-47420
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    CA, WA, NE, DE, OH, ME, TX
  • 제품 설명
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
  • Manufacturer
    On-X Life Technologies, Inc.

Manufacturer

On-X Life Technologies, Inc.
  • 제조사 주소
    On-X Life Technologies, Inc., 1300 E Anderson Ln Ste B, Austin TX 78752-1739
  • Source
    USFDA