Events

Airlight ROM brace (An Orthosis that encompases the knee joint) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Australian Orthotic Technologies 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-00090-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00090-1
  • 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
    Australian orthotic technologies received notification of failures on a small number of the ossur rehab universal airlight range of motion knee braces code b-222000000; whereby the braces have broken at the hinge. customers returned a small quantity (7%) of these braces that had failed under the same circumstance (locking hinge mechanism breakage) suggesting that there may be a potentially faulty batch. the manufacturer was advised of the issue and affected batch removed from stock.This action was initiated prior to consultation with the therapeutic goods administration.
  • 조치
    Australian Orthotic Technologies advised the customers of the locking hinge mechanism failure along with the instructions of how to test product integrity. ATO sales representative visited the customers and completed a swap out of affected batch to new batch. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Airlight ROM brace (An Orthosis that encompases the knee joint)
  • 모델명 / 제조번호(시리얼번호)
    Airlight ROM brace (An Orthosis that encompases the knee joint)Product Code: B-222000000 Batch Number: 091013Lot Number: 130827 ARTG Number: 135047
  • Manufacturer
    Australian Orthotic Technologies Pty Ltd

Manufacturer

Australian Orthotic Technologies Pty Ltd
  • Source
    DHTGA