Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) 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-2017-RN-01413-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-11-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 is recalling the affected batches of the logical 20 degree hooded xlpe liner. the batch numbers are displayed on the product labels. these devices are not intended for the market in australia, and had been distributed following a logistical error.There is no risk to patient safety as a result of this issue.
  • 조치
    Signature Orthopaedics is advising users to inspect stock and quarantine any remaining units from the affected batches. There is no additional safety risks or follow up required for implanted devices.

Device

  • 모델명 / 제조번호(시리얼번호)
    Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) Catalogue Numbers: 111-12-0250, 111-12-0660, 111-12-0652, 111-12-0656Batch Numbers: 77FAE, 78320, 78347, 7739B, 78334, 7739C-1ARTG Number: 277875 (Signature Orthopaedics Pty Ltd - Logical XLPE Liner - Non-constrained polyethylene acetabular liner)
  • Manufacturer

Manufacturer