Events

Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer flex Gen.1- 3.14.251 Reaming shaft flex. Gen.1- 3.15.252 Countersink reamer flex. Gen.2- 3.14.256 Reaming shaft flex. 46-52 Gen.2- 3.14.257 Reaming shaft flex. 54-64 Gen.2- 3.14.258 Reaming shaft flex. 60-68 Gen.2- 3.14.259 Shaft flex. Gen.1- 3.40.501 Countersink reamer flex. Gen.3- 55.02.1901 Reaming shaft flex. Gen.3- 55.02.1903 seleXys Shaft flex- 5502.00.2 Shaft flex- 3.14.545 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Mathys Orthopaedics 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-00794-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00794-1
  • 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
    The validated process for the flexible shaft provides directions for a combined manual and mechanical cleaning/disinfection procedure. if the mandatory manual process as described in the processing instruction cannot be ensured/ performed, instruments by mathys ltd with flexible shafts may not be used. mathys ltd received feedback from hospitals that although the guidelines for processing and sterilising instruments were followed, residues on the instrument were still found. therefore mathys has developed an update to the processing instructions for the concerned instruments.
  • 조치
    Mathys is notifying end users of the validated method for cleaning/disinfection of flexible shafts.

Device

Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer fl...
  • 모델명 / 제조번호(시리얼번호)
    Surgical Instruments with flexible shaftsDescription & ArticleRM Classic Countersink reamer flex Gen.1- 3.14.251Reaming shaft flex. Gen.1- 3.15.252Countersink reamer flex. Gen.2- 3.14.256Reaming shaft flex. 46-52 Gen.2- 3.14.257Reaming shaft flex. 54-64 Gen.2- 3.14.258Reaming shaft flex. 60-68 Gen.2- 3.14.259Shaft flex. Gen.1- 3.40.501Countersink reamer flex. Gen.3- 55.02.1901Reaming shaft flex. Gen.3- 55.02.1903seleXys Shaft flex- 5502.00.2Shaft flex- 3.14.545
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd