Events

DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-00976-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00976-1
  • 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 device recall of the charnley pin retractor & handle set due to the potential for breakage of the small extraction peg away from the pin. analysis of the pegs from the above affected lots identified the existence of microscopic cracks in the weld region. this could lead to decreased strength and a greater risk of instrument fracture under what would be normally acceptable conditions.
  • 조치
    Johnson & Johnson Medical Pty. Ltd. (JJM) is requesting the affected customer to inspect their inventory and quarantine the affected stock. JJM is making arrangements for a courier pick-up (free of charge) of the affected product and is issuing a credit note. This action has been closed-out on 07/06/2016.

Device

DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)
  • 모델명 / 제조번호(시리얼번호)
    DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)Part Number: 962004000Lot Numbers: OSA-149328, OSA-161157, OSA-181610ARTG Number: 137164
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia