Events

Cemented resurfacing patellar implant, Ø 33mm and 36mm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Amplitude 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-01013-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01013-1
  • 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
    It has been reported to amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. this may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
  • 조치
    Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.

Device

Cemented resurfacing patellar implant, Ø 33mm and 36mm
  • 모델명 / 제조번호(시리얼번호)
    Cemented resurfacing patellar implant, Ø 33mm and 36mmCemented resurfacing patellar implant - Ø 33mmReference Number: 1-0200833Batch Number: 236419Cemented resurfacing patellar implant - Ø 36mmReference Number: 1-0200836Batch Number: 236412ARTG Number: 216375
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd