Events

SMR Glenosphere Impactor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Lima Orthopaedics 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-2016-RN-00578-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00578-1
  • 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
    Lima orthopaedics has received complains about the intra-operative breakage of the glenosphere impactors/extractors.The breakage occurs at a location corresponding to the threaded section which is screwed into the glenosphere before impacting the glenosphere into the metal back glenoid through the connector.If the reported issue occurs during surgery, it may result in a slight prolongation of the surgical time. although unlikely, in a worst case scenario, the surgeon would be unable to remove the broken thread from the glenosphere cavity nor be able to remove and replace the glenosphere, therefore the broken tip would remain in the patient.
  • 조치
    Customers are advised to inspect stocks and quarantine the affected units prior to their return. This action has been closed out on 20/01/2017.

Device

SMR Glenosphere Impactor
  • 모델명 / 제조번호(시리얼번호)
    SMR Glenosphere ImpactorProduct Code: 9013.74.141Lot Numbers: 1390763, 14AA094, 14AA528, 15AA557ARTG Number: 176877
  • Manufacturer
    Lima Orthopaedics Australia Pty Ltd

Manufacturer

Lima Orthopaedics Australia Pty Ltd