Events

Synream Medullary Reamer Head Size 13.5mm 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-01241-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-12-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01241-1
  • 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 affected part number and lot number is etched as dimension 13.5mm while the actual dimension is 14mm.If a 14mm reamer head is labelled and etched as a 13.5mm, there is the potential that the surgeon would be advancing 1.0mm versus 0.5mm; thus, there is a risk of the reamer head jamming. surgical delay could occur as the reamer head is removed from the medullary canal and bone debris is removed or the reamer head is replaced with another reamer head. there is also the potential for damage to the bone.
  • 조치
    JJM is advising users to inspect stock and return any of the affected product to JJM for replacement with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Synream Medullary Reamer Head Size 13.5mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes