Events

Thoracic Pedicle Feeler 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-2017-RN-01337-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01337-1
  • 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
    Stryker has determined that a laser marking machine used to create the distance markings on the tip of the thoracic pedicle feeler has settings higher than those intended. this change leads to an increased energy being directed onto the tip of the thoracic pedicle feeler, causing material degradation where the laser marks exist.There is the potential for the tip of the thoracic pedicle feeler to break during use. if this occurs within the patient, migration of the broken tip could result in soft tissue or peripheral nerve injury requiring surgical intervention.
  • 조치
    Stryker is advising users to quarantine any affected product and contact their local Stryker representative to coordinate the return and replacement of affected product.

Device

Thoracic Pedicle Feeler
  • 모델명 / 제조번호(시리얼번호)
    Thoracic Pedicle FeelerItem Number: 6002-350-000 (contained within tray 6001035000-T)Serial Number: 10910ARTG Number: 175054
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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