Events

DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Implant Direct Oceania 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-2015-RN-01091-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01091-1
  • 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
    There is a possible safety issue with the retention of the drill when the dgde is in use. this discrepancy may lead to the possibility of the dgde dropping the drill. the sponsor's current data indicates that the possibility of this occurring is unlikely (less than 0.69%). in the unlikely event that the dgde drops the drill; there is a risk if the product is in use that the drill can possibly fall onto the patient, or into the patient’s oral cavity. the drill could be ingested or aspirated by the patient and this may lead to surgical intervention.
  • 조치
    Customers to return the affected products. Sponsor to replace the affected products. This action has been closed-out on 26/08/2016.

Device

DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender
  • 모델명 / 제조번호(시리얼번호)
    DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill ExtenderAffected Part Numbers: DGDE, CST, RBST, RCST, SPCST, BST, ICST, IBST.Affected Lot Numbers: 61928, 67055, 67345, 64895, 65405, 67474, 67479, 65410, 67474, 65409, 64898, 65357, 64898, 65357, 64898, 65406, 67474, 68254 and 68265, 65408, 64896.ARTG Number: 245673
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA