Events

Biolox Delta Ceramic Hip Components 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-01544-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01544-1
  • 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
    Smith & nephew is issuing this notification in relation to the ongoing use of all ceramic hip prostheses, including femoral ball heads and acetabular cup (shell) liners/ inserts that are either manufactured or distributed globally by smith & nephew. recent post-market surveillance suggests that ceramic fragments from fractured ceramic components of hip prostheses may remain in the joint during revision surgery, which may lead to premature wear in revision components if such revision components are made of non-ceramic materials. this may lead to a need for an additional revision surgery.
  • 조치
    This notification has been issued by Smith & Nephew to caution against the use of non-ceramic components when revising fractured ceramic components used in hip arthroplasty and inform surgeons of changes to the warnings in Smith & Nephew Instructions for use (IFU). Additional information is provided in the letter to surgeons and the revised IFU.

Device

Biolox Delta Ceramic Hip Components
  • 모델명 / 제조번호(시리얼번호)
    Biolox Delta Ceramic Hip ComponentsBiolox Delta Ceramic Femoral HeadARTG Number: 218138R3 Biolox Delta Ceramic LinerARTG Number: 218185 EP-FIT Biolox Delta Ceramic InsertARTG Number: 222565
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd