Events

LP rotate, sizes 25-27 cat.1-6. 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ossur Asia-Pacific 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-00320-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00320-1
  • 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
    Ossur is recalling the product due to a defect discovered during assembly (outer tube threads not machined correctly in the cnc process). the threads of the outer tube of the shock module of lp rotate were too short, resulting in insecure assembly to the foot blade. use of the product may cause the patient to fall, as the shock module can become loose from the foot blade.The user may also hear noise coming from the foot module. the failure could possibly be noticed by users as they will feel looseness on ankle foot device. if use is continued, connection of shock adapter to foot blade might break and user may fall.This recall action was undertaken prior to notifying tga.
  • 조치
    Ossur is replacing all the affected devices with the unaffected units.In case the customers are wearing a faulty product, Ossur is recommending scheduling a visit to have the product replaced with a new LP Rotate that is currently available.

Device

LP rotate, sizes 25-27 cat.1-6.
  • 모델명 / 제조번호(시리얼번호)
    LP rotate, sizes 25-27 cat.1-6. Model number: E443296Product numbers LRP062, LRF062, LRPU62, and LRFU62. Manufacturing Lot Number: HF141022ARTG Number: 141148
  • Manufacturer
    Ossur Asia-Pacific

Manufacturer

Ossur Asia-Pacific