Events

QuikFlap Neuro Implants 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-2018-RN-00682-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00682-1
  • 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 current packaging and ifu indicate a five-year shelf life. during long-term product testing, it was discovered that after a three-year term, there is a potential for the external packaging (sterile barrier) to become compromised. such compromised packaging results in the loss of the vacuum seal allowing for contamination of the inside peel pouch. a breach of the outer peel pouch has only been observed with packages at shelf life end and after excessive transportation testing.To date, medtronic have not received any complaints as a result of this issue.
  • 조치
    Stryker is advising customers to quarantine affected stock to prevent further use. Stryker representatives will contact customers to help coordinate the return of any affected product. In the event this device has been recently implanted, surgeons are advised to monitor for signs of infection as per their normal processes.

Device

QuikFlap Neuro Implants
  • 모델명 / 제조번호(시리얼번호)
    QuikFlap Neuro ImplantsMultiple Item NumbersMultiple Lot Numbers ARTG Number: 295882(Stryker Australia - Cranofacial fixation plate, non-biodegradable)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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