Alginot (dental impression material); AlgiNot Cartridge Intro Kit; AlgiNot Cartridge Refill; AlgiNot Sample Pack; AlgiNot FS Cartridge Intro Kit; AlgiNot FS Cartridge Refill; AlgiNot FS Sample Pack; AlgiNot Volume Refill; AlgiNot Volume Intro Kit; AlgiNot FS Volume Refill; AlgiNot FS Volume Intro Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ormco Pty 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
    RC-2012-RN-00674-3
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2012-07-05
  • 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 current instructions for use (ifu's) for alginot include product specifications and instructions that are not indicative of the actual performance of the product. more specifically, the ifu's incorrectly state the work time/mouth removal time.
  • 조치
    Kerr Australia is providing updated Instructions for Use (IFU)

Device

  • 모델명 / 제조번호(시리얼번호)
    Alginot (dental impression material); All product lots within shelf lifeAlgiNot Cartridge Intro Kit; Part No. 33034AlgiNot Cartridge Refill; Part No. 33035AlgiNot Sample Pack; Part No. 33141AlgiNot FS Cartridge Intro Kit; Part No. 33816AlgiNot FS Cartridge Refill; Part No. 33817AlgiNot FS Sample Pack; Part No. 33848AlgiNot Volume Refill; part No. 34680AlgiNot Volume Intro Kit; Part No. 34681AlgiNot FS Volume Refill; Part No. 34682AlgiNot FS Volume Intro Kit; Part No. 34683
  • Manufacturer

Manufacturer