Events

rHead Radial Head and Uni-Elbow System 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-01347-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01347-1
  • 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 conducted a review of the currently available data of the stryker rhead radial head and uni-elbow system, and it was found to be inconclusive to continue supporting the performance of the device. the system is intended for replacement of the proximal end of the radius. this includes replacement of the radial head for degenerative or post-traumatic disabilities, presenting pain, crepitation and decreased motion at the radio humeral and/or proximal radio ulnar joint with joint destruction or subluxation visible on x-ray and resistance to conservative treatment.Post-operatively, the following may occur; implant loosening (septic and aseptic), instability (mod-severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement and heterotopic ossification.
  • 조치
    Stryker is advising customers to inspect inventory for affected product and quarantine it immediately. Stryker will arrange collection of goods from affected sites. Health care professionals that have patients using the Stryker rHead Radial Head/Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care and be aware of this issue when doing so.

Device

rHead Radial Head and Uni-Elbow System
  • 모델명 / 제조번호(시리얼번호)
    rHead Radial Head and Uni-Elbow SystemMultiple Item Numbers (see attached)All Lot NumbersARTG Numbers: 238712 (Stryker Australia Pty Ltd - Prosthesis, internal, joint, elbow, radial component)240014 (Stryker Australia Pty Ltd - Coated elbow humerus prosthesis)240015 (Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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