True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and tissue) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Allegra Orthopaedics Limited 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
    RC-2015-RN-00926-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-09-17
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has performed an investigation and determined that the affected lots were not manufactured according to specification in relation to a particular dimension. this created a loose fitting of the blade when it was connected to the power equipment hand piece, resulting in the ineffective oscillation of the blade.
  • 조치
    Allegra Orthopaedics is requesting users to inspect their stocks and quarantine all affected units. Allegra will replace affected stock with a blade of similar size and specification as an interim measure. This action has been closed-out on 04/03/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and tissue)Lot Numbers: 15040200 and 15039800ARTG Number: 134917
  • Manufacturer

Manufacturer