Events

Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel 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-2016-RN-00235-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00235-1
  • 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 content of the packaging received may not match the label on the package. the label on the package may indicate a 1.5 mm cortex screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.108 and lot number 9682574. however, the screw in the package may be a 1.5 mm locking screw with stardrive recess, self-tapping, length 8 mm, part number 02.214.008 and lot number 9674525. the difference between these two screws is that the locking screw has a threaded head profile while the cortex screw does not. if the incorrect screw is used, there may be a small surgical delay while a correct screw is located.
  • 조치
    Johnson & Johnson Medical (JJM) is advising users to inspect and quarantine any affected stock and return to JJM. This action has been closed-out on 27/01/2017.

Device

Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, se...
  • 모델명 / 제조번호(시리얼번호)
    Locking Screw Stardrive 1.5 mm and Cortex Screw Stardrive 1.5mm Cortex Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steel Part Number: 02.214.108 Lot Number: 9682574Locking Screw Stardrive 1.5 mm, self-tapping, length 8 mm, stainless steelPart Number: 02.214.008Lot Number: 9674525 (This lot was not distributed in Australia)ARTG Number: 157068
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes