Events

5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal) 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-2014-RN-00593-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-05-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00593-1
  • 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 manufacture, the notching completed on one specific machine may have been started too close to the end of the shank. in some products (approximately 1/1000), there may be missing notches, partial notches or no notches at all. the listed cutting accessories are manufactured with notches at the proximal end of the bur. the notch is a feature on the bur that is used to retain and control the exposure of the bur within the drill/attachment. the correct number of notches varies from 2 to 5, based on the specific product number.
  • 조치
    Stryker is requesting their customers to quarantine all affected stock and advising that they will be contacted to organize for the return of the product.

Device

5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round...
  • 모델명 / 제조번호(시리얼번호)
    5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal)Multiple item numbers and lot numbers affected
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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