Events

Kirschner Wire 1.6 mm, with drill tip, length 200 mm 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-01210-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-12-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01210-1
  • 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 kirschner wire is made from co35ni35cr20mo10 (mp35n) which is cobalt based alloy containing 35% nickel. however, the label and technique guide incorrectly indicate that the devices are made of stainless steel. the product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices. although unlikely, there is a potential for surgeons to use the affected products on patients with a nickel allergy, which could lead to an allergic reaction. as mp35n is a more corrosion-resistant alloy and more biocompatible than stainless steel, the likelihood of a patient being exposed and sensitised to a higher amount of nickel or other alloys is low compared to a product manufactured from stainless steel.
  • 조치
    The sponsor is advising users to review the instructions listed in the customer letter. Users are not requested to return the product.

Device

Kirschner Wire 1.6 mm, with drill tip, length 200 mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes