Events

Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty) 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-2016-RN-00808-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00808-1
  • 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 steam sterilisation validation with 3 half cycles (2 minutes, 132°c), it was identified that the trident constrained liner impactor tips do not meet the required sterility assurance level (sal) of 10-6.Please note that these instruments are sterilised at the hospital prior to surgery and are not distributed as sterile from stryker to customers. due to this inability to meet the sal, the instrument may be non-sterile and this could lead to a possible infection.
  • 조치
    Stryker is advising users to inspect stock and quarantine any affected product for return. Stryker is providing information about alternative surgical methods of locking the insert into the shell. This action has been closed-out on 28/02/2018.

Device

Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts dur...
  • 모델명 / 제조번호(시리얼번호)
    Trident Constrained Liner Impactor Tips (Used for implantation of Trident Constrained Inserts during hip arthroplasty)Item Numbers: 21992022, 21992028, 21992032All Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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