Events

CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2016-RN-00484-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-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
    The pivot cinchlock ss knotless anchor is a non-degradable implant device intended for the fixation of soft tissue to bone.Several complaints have been received relating to the pull wire breaking. there are two modes of failure identified for the pull wire; near the inserter handle and at the most distal tip where the wire ends with a larger diameter tip.The broken pull wire may spring out of the inserter handle that may injure the user. inserter components may break or disassemble leading to minor surgical delay to remove fragments or fragments left in bone after the procedure.
  • 조치
    Stryker is advising users to inspect and quarantine any of the affected items. Affected stock can be returned to Stryker for replacement with unaffected stock. This action has been closed out 01 Feb 2017

Device

CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)
  • 모델명 / 제조번호(시리얼번호)
    CinchLock SS Knotless Anchor with Inserter (intended for the fixation of soft tissue to bone)Catalogue Number: CAT02462Lot Numbers: 15120801, 15121401, 16010402, 16011901, 16012501ARTG Number: 229717
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA