Events

Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport 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-00531-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00531-1
  • 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 found that there is the potential for loosening of the safety clips from the intended position on the quick release mechanism of the transport struts. in the case of no safety clip and/or overloading, the frame may loosen, bend or break in time, causing frame stability collapse.
  • 조치
    Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate return of the product and provide credit. Clinicians are advised to inspect if the Safety Clips are still in place when patients come in for routine follow up examination and replace the Safety Clips, and to consider contacting patients that do not show up for routine follow up examination. The need to replace the entire Hoffmann LRF Bone Transport if indicated should also be considered.

Device

Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport
  • 모델명 / 제조번호(시리얼번호)
    Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone TransportItem Number: 49330401 Lot Numbers: J49236, V07241, V30655, V47575, V49404 ARTG Number: 258035
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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