Events

SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 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-01520-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01520-1
  • 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
    There is the potential that the affected lot of the synream flexible shaft may have been manufactured with a non-symmetric hexagonal coupling which may result in the reamer shaft not fitting into the reamer heads. in the event that the flexible shaft cannot be assembled with the reamer head, surgical delay may occur if another device is not available in the surgical suite.
  • 조치
    JJM is advising customers to immediately quarantine affected product, and then contact JJM who will arrange for return of the product and replacement. This action has been closed-out on 11/05/2017.

Device

SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary r...
  • 모델명 / 제조번호(시리얼번호)
    SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system)Part Number: 352.040Lot Number: 9946822The SynReam Flexible Shaft may be contained within the following two kitsLS SynReamKit Number: ZXAUTR1671 Equipment Number: 3000072587 SynReam Kit Number: ZXAUTR2316Equipment Number: 3000108391ARTG Number: 153666
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes