Events

DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm. 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-2015-RN-00723-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00723-1
  • 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 pty. ltd. (jjm) is issuing a recall for all lots of the depuy synthes socket, hexagonal ø 4.0mm/11.0mm. the socket is a cannulated instrument used to insert the end caps in the proximal femoral nail anti-rotation (pfna), pfna-ii, and the antegrade femoral nail (afn). there is a potential for the socket-hex tip to break into fragments during use if too much force is applied.As the affected item has been reported to break intra-operatively, there is potential for surgical delay while the fragments are retrieved. consequently, surgical delay may occur while a replacement instrument or alternative device is located to insert the end cap. in addition, an adverse tissue reaction may possibly occur if any stainless steel fragments from the socket are not retrieved from the patient.
  • 조치
    JJM is requesting their customers to immediately check their inventory to determine if their facility has any affected product. If affected stock is identified quarantine prior to organising its return to JJM.

Device

DePuy Synthes Socket, Hexagonal Ø 4.0mm/11.0mm.

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes