Events

Device Recall Fixed Cervical Screws 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Genesys Orthopedic Systems, LLC 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
    64421
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0921-2013
  • 사례 시작날짜
    2013-02-20
  • 사례 출판 날짜
    2013-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-09-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116108
  • 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 intervertebral body - Product Code KWQ
  • 원인
    Manufacturing residue may be present on the cervical screws. use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
  • 조치
    Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.

Device

Device Recall Fixed Cervical Screws
  • 모델명 / 제조번호(시리얼번호)
    Part Number: GCSF37512 and Lot Number: 0243
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA Nationwide Distribution including the states of: CA and TX.
  • 제품 설명
    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System || Product Usage: is intended for anterior screw fixation to the cervical spine.
  • Manufacturer
    Genesys Orthopedic Systems, LLC

Manufacturer

Genesys Orthopedic Systems, LLC
  • 제조사 주소
    Genesys Orthopedic Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Source
    USFDA