VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-2012-RN-01147-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-13
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    During insertion of viper large diameter long screws in high-torque circumstances (such as placement into the ilium) the screw shank has the potential to separate from the polyaxial head. the disassembly of the screw requires that the shank be removed either via the drive feature in the shank or via alternate methods.
  • 조치
    Quarantine and return affected products to Johnson & Johnson Medical.

Device

  • 모델명 / 제조번호(시리얼번호)
    VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)Multiple Product Codes All Lot NumbersARTG Numbers: 145290 & 178040
  • Manufacturer

Manufacturer