Events

Spectra System/Legacy Guided Surgery Handle Kit Inserts 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-2017-RN-01423-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01423-1
  • 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
    Implant direct oceania pty ltd is informing users of a recall of four (4) lots of spectra system/legacy guided surgery handle kit/inserts due to receiving 3 complaints on these products. through the reporting process, implant direct have found that the g-hk guided surgery handle inserts may be out of implant direct specification. the 3.4mm guide insert will not allow the 3.4 drill to pass through, since the diameter is too small. in addition, the 2.3mm guide may be too large for the drill. these discrepancies may lead to the possibility of a delay in procedure for the patient if the drilling sequence is discontinued or the clinician would need to continue the surgical procedure without the use of the drill guide. there have been no injuries as a result of this issue.
  • 조치
    Implant Direct is advising users to inspect stock and return affected units.

Device

Spectra System/Legacy Guided Surgery Handle Kit Inserts
  • 모델명 / 제조번호(시리얼번호)
    Spectra System/Legacy Guided Surgery Handle Kit InsertsPart Numbers: G-HKKit Lot Numbers: 42562, 52987, 64245 and 74772ARTG Number: 296286
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA