Events

AVS PL SPACER (Used as an aid in spinal fixation) 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-2014-RN-01131-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01131-1
  • 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 above catalogue numbers are specific to the us and supplied with the us labelling which has a different indication then those devices supplied outside of the us. specifically, the us versions indicated use with autogenous bone graft in patients with degenerative disc disease (ddd) at one level or two contiguous levels from l2 to s1. the australian indication does not include the limit to the contiguous levels or spinal region (l2-s1).
  • 조치
    Stryker is requesting their customer to identify and return any affected stock. This action has been closed-out on 01/03/2016. This action has been closed-out on 01/03/2016.

Device

AVS PL SPACER (Used as an aid in spinal fixation)
  • 모델명 / 제조번호(시리얼번호)
    AVS PL SPACER (Used as an aid in spinal fixation)AVS PL SPACER 7 X 20 X 4° 9MMCatalogue Number: 48340074Lot Numbers: 30646, 33494, 39184AVS PL SPACER 8 X 20 X 4° 9MMCatalogue Number: 48340084Lot Numbers: 33549, 38164, 38652, 39007, 39160AVS PL SPACER 7 X 25 X 4° 8MMCatalogue Number: 48345074Lot Number: 39188AVS PL SPACER 8 X 25 X 4° 8MMCatalogue Number: 48345084Lot Numbers: 39150, 38183ARTG Number: 178870
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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