Events

DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit) 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-2013-RN-00482-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00482-1
  • 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) has identified the potential for the reclaim reamer extension tabs to break off. 9 complaints worldwide since 2011 have been received reporting tab breakage. none of the complaints have indicated fragments were left in patients.
  • 조치
    JJM is advising that users should check the condition of the reamer extension tabs on a regular basis, especially before and after usage. Any reamer extensions showing signs of cracks in the tab area or having broken or missing tabs, should be returned to JJM. Other devices from the affected lots may continue to be used until a design change is implemented and new devices are available.

Device

DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)
  • 모델명 / 제조번호(시리얼번호)
    DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)Part Number: 297500500Lot Numbers: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586. NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023 ARTG Number: 191616
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia