Events

SwiveLock SP Suture Anchor 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-00463-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00463-1
  • 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
    It has been determined that there is an issue with specific batches of the self-punching eyelet contained within the arthrex swivelock sp suture anchor which may cause the eyelet to break on insertion in hard bone.Please note that there is no impact to the patient if the device has been implanted successfully.
  • 조치
    Device Technologies Australia (DTA) is requesting users to immediately discontinue use of the affected devices and to inform all relevant personnel at their facility of the recall notice. Users are further requested to quarantine their affected stock and return a completed Reply Fax Form, advising the quantity of affected stock. Users are advised that credit will be issued upon DTA's receipt of the returned items.

Device

SwiveLock SP Suture Anchor
  • 모델명 / 제조번호(시리얼번호)
    SwiveLock SP Suture AnchorProduct Codes: AR-2323BSLM, AR-2323PSLM, AR-2324BCM, AR-2324PSLM, AR-2600SBS-5, AR-2600SBS-7Multiple Products and Batch NumbersARTG Numbers: 126657 and 164046
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd