Events

Neoss Guide – Drill-Hubs I to V included in Neoss 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Neoss 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-2015-RN-00917-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00917-1
  • 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
    These batches of drill-hub i may not be functioning as intended (drill does not latch completely in the drill-hub i).The upper part of the bore in the drill-hub i is slightly smaller which results in the drill not being seated correctly which means that this drill-hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. there is also a risk of drill loosening or not rotating as expected.No incidents have been reported in australia.
  • 조치
    Customers are asked to inspect their stock on hand and to quarantine affected units prior to their return to Neoss as per the instructions in the Customer Letter.

Device

Neoss Guide – Drill-Hubs I to V included in Neoss
  • 모델명 / 제조번호(시리얼번호)
    Neoss Guide – Drill-Hubs I to V included in NeossGuide Kit Ø3.5 - Ø4.5 (art no 51153) Identifier #9040Batch Number: 15182, 15586, 16030ARTG Number: 119446
  • Manufacturer
    Neoss Australia Pty Ltd

Manufacturer

Neoss Australia Pty Ltd