Events

Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants) 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-2015-RN-00554-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00554-1
  • 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
    There is a potential that the packaging integrity (sterile barrier) of the packaging type kit i may be compromised by transportation. a compromised sterile barrier could result in the surgeon selecting a back-up device or, if not recognised, an unintended implantation of a potentially non sterile device. the packaging type kit i consists of a white cardboard box, an outer peel pouch, and an inner peel pouch.
  • 조치
    Stryker is notifying hospitals and surgeons of the issue and recovering stock supplied to hospitals. Surgeons are advised of the potential hazards involved in the implantation of devices where the sterile barrier has been breached. This action has been closed-out on 18/08/2016.

Device

Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)
  • 모델명 / 제조번호(시리얼번호)
    Stryker Trauma rHead Recon, Bipolar & Radial Stem Implants (Components of elbow joint implants)rHead Recon Stem Implant non-coated:Size 1 Item: RCNS160, Lot: 19804S2Size 2 Item: RCNS260, Lot: 19773-S2Size 3 Item: RCNS360, Lot: 19807S2Bipolar stem implant #1 Item RCNS1, Lot 19716S2Bipolar stem implant #3 Item RCNS3, Lot19720-S2Bipolar stem implant #4 Item RCNS4, Lot19816-S2Radial stem implant #1 Item RHAS1, Lot19778S2 Radial stem implant #4 Item RHAS4, Lot19814-S2
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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