Events

Triathlon TS Tibial Augments Sizes 3 and 6 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-00162-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00162-1
  • 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 discovered that the product/lot combinations referenced above may contain the incorrect size implant from what is labelled on the box.The triathlon ts tibial augments are laser marked with lot and catalogue number. although the product packaging for the four lots may not match the product contained within, the laser marked details on the implant would increase the likelihood that the surgeon or surgical staff would recognise that the incorrect implant was contained in the package.The size 3 and 6 triathlon ts tibial augments are also visibly different in size. the tibial augment implant can be compared to the corresponding size tibial augment trial (item number: 5545t301 and 5546t601) which would alert a user to a size mismatch.
  • 조치
    Stryker is advising users that patients implanted with the affected products should continue to be followed up as per the normal protocol established with their surgeons.

Device

Triathlon TS Tibial Augments Sizes 3 and 6
  • 모델명 / 제조번호(시리얼번호)
    Triathlon TS Tibial Augments Sizes 3 and 6Item Number: 5545A3301, 5546A601Lot Numbers: ER9WA1AARTG Number: 242298(Stryker Australia Pty Ltd - Knee wedge)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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