Events

STREAMLINE CT CERVICOTHORACIC SYSTEM 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
    69033
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2573-2014
  • 사례 시작날짜
    2012-09-10
  • 사례 출판 날짜
    2014-09-03
  • 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=129374
  • 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
    Appliance, fixation, spinal interlaminal - Product Code KWP
  • 원인
    Some set screw thread profiles were found not to be within specifications.
  • 조치
    The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.

Device

STREAMLINE CT CERVICOTHORACIC SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
  • 제품 설명
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW || REF 26-SETSCREW || NON-STERILE, SINGLE USE, RX ONLY
  • 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