Events

MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7 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-2017-RN-01493-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01493-1
  • 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 packaging of certain sizes and lots of the above-referenced product may contain the incorrect product and/or label. two reports were received with the product/label discrepancy. in one report, the labelling of the implant box outer label stated size 2 rm/ll, and the labelling of the implant sticker (patient label) located inside the outer box state size 7 rm/ll. the correct implant size 2 rm/ll was inside the box. the patient label was incorrect in this report. the second report described that a size 2 implant was in a box labelled as a size 7 implant.
  • 조치
    Stryker is advising users to quarantine affected stock immediately. Customers should contact their Stryker representative to arrange for return of affected product.

Device

MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7
  • 모델명 / 제조번호(시리얼번호)
    MCK Tibial Baseplate-RM/LL-SZ 2 and MCK Tibial Baseplate-RM/LL-SZ 7Item No: 180612; Lot No: 26080317-01Item No: 180617; Lot No: 26150217-01ARTG Number: 242173
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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