Events

GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Surgical 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-2013-RN-00912-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00912-1
  • 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 manufacturer has advised that the tyvek lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. during a total knee arthroplasty surgery, the user will most likely notice the inadequate seal and request another device.
  • 조치
    Smith & Nephew is advising users to inspect products and quarantine affected devices. Affected devices will be replaced by Smith & Nephew.

Device

GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    GENESIS II PS Articular Inserts (internal tibial component for knee prosthesis)GENESIS II PS Articular Insert Size 3-4 13mmCatalogue Number: 71420820Lot Number: 12GT20824GENESIS II PS High Flexion Insert Size 3-4 9mmCatalogue Number: 71421508Lot Number: 12GT20822ARTG Number: 114463
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd