Events

Acetabular Cup Introducer (32mm) 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-2017-RN-01385-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01385-1
  • 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 (jjm) has identified an issue with the acetabular cup introducer (32mm) where the nylon ejector slug may melt during the autoclave process. this may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement.
  • 조치
    JJM is requesting Customers: 1. Immediately inspect the device(s) in your possession to determine if your facility has affected product. If you do please quarantine this product prior to returning it to JJM; 2. Return a copy of the supplied acknowledgement form, even if you do not have any affected product, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com; 3. Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service on 1300 562 711; 4. Forward the recall notice to anyone in your facility who needs to be informed; and 5. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).

Device

Acetabular Cup Introducer (32mm)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes