Events

RCI HA ACL Screw 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Signature Orthopaedics 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-2018-RN-00484-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-05-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00484-1
  • 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
    Signature orthopaedics has identified that certain batches may be mislabelled, with the packaged component's size not corresponding to the label. therefore, the product intended to be used for the procedure may not be included in the packaging.
  • 조치
    Signature Orthopaedics is advising users to quarantine affected stock for return. Replacement stock or a credit note will be issued.

Device

RCI HA ACL Screw
  • 모델명 / 제조번호(시리얼번호)
    RCI HA ACL ScrewCatalogue Number: 35130416Batch Numbers: 750ED, 7515DManufacturing Date: 31-7-16Expiry Date: 31-7-21ARTG Number: 193153(Signature Orthopaedics - Prosthesis, internal, ligament, anchor)
  • Manufacturer
    Signature Orthopaedics Pty Ltd

Manufacturer

Signature Orthopaedics Pty Ltd