Events

Apex 10mm reamer 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Global Orthopaedic Technology 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-00419-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00419-1
  • 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
    Sequential reaming of the patient's femur was being carried out during a total hip replacement(thr) procedure. following the use of the 8mm reamer, the 10mm reamer was introduced. during reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. a distal window was cut into the femur, and the broken section of the reamer removed. under torque the reamer broke at a weld joint. the joint was insufficiently strong.This action is undertaken prior to notifying the tga.
  • 조치
    Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers.

Device

Apex 10mm reamer
  • 모델명 / 제조번호(시리얼번호)
    Apex 10mm reamer ARTG Number: 183711CER-227: 16-May-2011- 8.5mm REAMER Lot L0805CER-257: 10-Aug-2011 - 16mm REAMER Lot L0805CER-358: 18-0ct -2012 - 10mm REAMER Lot L0805
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd