Events

Device Recall Streamline 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 PIONEER SURGICAL TECHNOLOGY, INC. 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
    69036
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2616-2014
  • 사례 시작날짜
    2013-06-14
  • 사례 출판 날짜
    2014-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129377
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • 원인
    The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
  • 조치
    Pioneer Surgical sent a Product Field Action letter on July 7, 2013, to all affected customers. The letter described the affected product and issue, and provided instructions for return of the recalled product. All 9 affected instruments were returned to Pioneer Surgical, reconditioned and sent back to the field. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Device

Device Recall Streamline
  • 모델명 / 제조번호(시리얼번호)
    Lot number: 148062, 148440
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including TX, CA, IL, and FL.
  • 제품 설명
    Streamline MIS Spinal Fixation System Fixed Rod Holder || NON STERILE, Rx only || The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
  • Manufacturer
    PIONEER SURGICAL TECHNOLOGY, INC.

Manufacturer

PIONEER SURGICAL TECHNOLOGY, INC.
  • 제조사 주소
    PIONEER SURGICAL TECHNOLOGY, INC., 375 River Park Cir, Marquette MI 49855-1781
  • 제조사 모회사 (2017)
    RTI Surgical Inc
  • Source
    USFDA