Events

CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic 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-00418-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00418-1
  • 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
    The incorrect label was applied to the product that is the subject of this action. certain lots of the chisel blades that were shipped to your facility may be labeled as “not for human use; for veterinary use only”.
  • 조치
    The incorrect label was applied to the product that is the subject of this action. Certain lots of the Chisel Blades that were supplied may be labelled as “NOT FOR HUMAN USE; FOR VETERINARY USE ONLY” This action has been closed-out on 03/03/2016.

Device

CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and s...
  • 모델명 / 제조번호(시리얼번호)
    CHISEL BLADES(used in conjunction with the conventional chisel handle (part 399.540) to cut and shape bone during orthopedic surgery)Chisel Blade, long, width 10 mmP/N: 399.555Lot numbers: A7OA30, T921923, T933948 & 935423 Chisel Blade, long, width 16 mmP/N: 399.565Lot numbers: A7QA37 & T936951Chisel Blade, long, width 25 mmP/N: 399.575Lot numbers: A7OA36, T937762 & T966630P/N: 399.585Lot numbers: A7OA30 & T939691ARTG number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes