Events

Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit) 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-2017-RN-00304-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00304-1
  • 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
    Johnson & johnson medical have received a complaint that the location slot for the screw holding sleeve was machined 3 mm out of position. the presence of a screwdriver, (part number 314.560) which is not manufactured to specification, may result in a surgical delay due to the non-conformance. the combination of the non-conforming screwdriver and a retaining sleeve will result in a situation where the surgeon will have minor difficulty interfacing the screw with the driver and sleeve, but the surgeon should still be able to insert the screw. it is important to note that the surgeon may opt to utilise the screwdriver without the retaining sleeve. the resulting surgical delay is not anticipated to be clinically significant (<15 minutes) and no additional intervention is anticipated.
  • 조치
    Customers are advised to quarantine and return the affected stock in their possession to JJM.

Device

Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as...
  • 모델명 / 제조번호(시리얼번호)
    Screwdriver Shaft, hexagonal, large, diameter 3.5mm, length 165mm, for Quick Coupling(Supplied as part of the fixation system implantation kit)Part Number: 314.560Lot Number: 7722501ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes