Events

VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2015-RN-01262-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01262-1
  • 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
    During a product presentation it has been recognised that a screw is not held by the screwdriver blade. the missing retaining function is caused by the inner torx of the screws partly being out of specification. investigations have revealed that screws might exceed given tolerances. a missing retaining function can lead to the surgeon having difficulties to pick the screw out of the screw rack without any further means, such as tissue forceps or other forceps, or during transfer of the screws. difficulties during pick up or transfer of the screws could potentially cause additional time under anaesthesia due to prolongation of surgery.
  • 조치
    Stryker is advising users that the affected screws can be continued to be used and will be replaced once unaffected stock is available. This action ha been closed-out on 29/08/2016.

Device

VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432
  • 모델명 / 제조번호(시리얼번호)
    VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432Multiple Lot Numbers affectedIncluded in VariAx Compression EPS system trayCatalogue Number: 940081-TAll lot numbers affectedARTG Number: 239272
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA