Events

Device Recall Spinal Jaxx Interbody Fusion Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Neuropro Spinal Jaxx 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
    79559
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1350-2018
  • 사례 시작날짜
    2018-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162646
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 원인
    The implant size is incorrectly etched on the implant. the size listed on the box is correct.
  • 조치
    The firm called the consignee using a phone script. Additional information requested regarding whether any instructions were provided to the consignee regarding what to do with the recalled devices.

Device

Device Recall Spinal Jaxx Interbody Fusion Device
  • 모델명 / 제조번호(시리얼번호)
    Lot 1599, Expiration date: 10/03/2018
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The devices were distributed in California.
  • 제품 설명
    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L || Product Usage: || The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
  • Manufacturer
    Neuropro Spinal Jaxx

Manufacturer

Neuropro Spinal Jaxx
  • 제조사 주소
    Neuropro Spinal Jaxx, 6337 Falling Brook Dr, Burke VA 22015-4031
  • Source
    USFDA