PFNA Nails (used during internal fixation surgery) 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-01266-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-24
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    It was discovered that the above part and lot numbers may have the incorrect anodised colour. an implant with the incorrect anodised colour would not cause harm to the patient. if the user identifies the nonconformity during surgery, marginal surgical delay may occur while an alternate implant is located.
  • 조치
    JJM is advising users to inspect and quarantine affected stock for return to JJM. This action has been closed-out on 05/09/2016. This action has been closed-out on 05/09/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    PFNA Nails (used during internal fixation surgery)PFNA ø10 125° L240 TAN Part Number: 472.260S, Lot Number: 7913867PFNA ø11 125° L240 TAN Part Number: 472.261S, Lot Number: 2812685PFNA ø10 long r 125° L340 TAN Part Number: 472.275S, Lot Number: 2806520ARTG Number: 161140
  • Manufacturer

Manufacturer