Events

BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Corin 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-01518-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01518-1
  • 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
    Data from sources external to corin suggest that ceramic fragments from fractured ceramic components may remain in the joint following revision surgery, which can lead to premature wear of revision components if such revision components are made of non-ceramic materials. as a result, the instruction within the ifu for corin’s biolox delta ceramic components have been updated in respect of recommended actions in the case of revisions.
  • 조치
    The IFU is being revised to include the following information in the ‘Warnings & Precautions’ section: In the case of revision due to a fractured ceramic component, when keeping a well fixed stem, the modular head must be replaced with a Biolox Option modular head where available. If a Biolox Option modular head is not available, in addition to revising the modular head, the femoral stem must also be revised to provide a suitable taper to which a new ceramic femoral ball head can be attached. In the event of revision not due to fracture of a ceramic component, when keeping a well fixed stem, the modular head must be replaced with a metal modular head or a Biolox Option ceramic modular head only.

Device

BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner
  • 모델명 / 제조번호(시리얼번호)
    BIOLOX delta ceramic componentsBiolox Delta Modular Head and Trinity Ceramic LinerAll Part Number / Lot Codes ARTG Numbers: 211371 and 210774
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd