Events

APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M Australia 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-2014-RN-01135-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-10-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01135-1
  • 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
    Product content did not match label. a total of 20 boxes (each box contains 5 brackets) of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"" with lot # ft1dg were supplied to 3 orthodontists (end user) in australia in the period 28 july 2014 - 7 august 2014. outer pack label packaging and individual blisters were labelled correctly. the type of bracket supplied within the blister was not correct. the incorrect bracket was ""apc plus victory series twin upper left/right 1st bicuspid with no hook"" instead of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"".
  • 조치
    This action was undertaken prior to approval of the recall strategy by the TGA. Orthodontists supplied with the affected lot were notified. Orthodontists returned affected lots and 19 of the 20 boxes were received. 1 box was not returned. The retrieval rate was 95 %. All products returned were in the original packaging (unopened).

Device

APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal...
  • 모델명 / 제조번호(시리얼번호)
    APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)ARTG Number: 219341
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd