MATRIX CORONAL BENDER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SYNTHES (CANADA) LTD. 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
    54029
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-06-20
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Synthes (canada) ltd. received notification from its supplier synthes usa that a medical device recall was being initiated for the matrix coronal bender part numbers 03.632.040 and 03.632.041 due to complaints received for reported bender tips breaking while surgeons are attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field product consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon).

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 03.632.040 (Lot serial: LOTS T969999 AND LOWER); Model Catalog: 03.632.041 (Lot serial: LOTS T969999 AND LOWER)
  • 제품 설명
    MATRIX CORONAL BENDER
  • Manufacturer

Manufacturer