Events

Tension Band Pins (Internal fixation pins) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical & Optical Instruments 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-2014-RN-00449-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00449-1
  • 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
    Specific lots of tension band pins manufactured between july 2009 and march 2011 are being recalled because they were manufactured with astm f138 stainless steel but should have been manufactured with astm a276 stainless steel. both standards are grade 316l stainless steel and contain the exact same chemical elements but in different concentrations. although the biocompatibility was only tested on astm f138 there is no evidence to indicate that astm a276 is not biocompatible.
  • 조치
    Medical + Optical is contacting their customers to arrange for the return of affected devices.

Device

Tension Band Pins (Internal fixation pins)
  • 모델명 / 제조번호(시리얼번호)
    Tension Band Pins (Internal fixation pins)Part Numbers:TB-1550K-SLot Number: 223007TB-1570K-SLot Numbers: 220788, 230952 & 233742TB-1590K-SLot Numbers: 218700, 221465 & 223009ARTG Number: 99821
  • Manufacturer
    Medical & Optical Instruments Australia Pty Ltd

Manufacturer

Medical & Optical Instruments Australia Pty Ltd