Events

Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 X Spine Systems 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
    71357
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1823-2015
  • 사례 시작날짜
    2015-04-07
  • 사례 출판 날짜
    2015-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137421
  • 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, spondylolisthesis spinal fixation - Product Code MNH
  • 원인
    The continuous radius rod should measure 50mm in length but actually measures 45mm in length.
  • 조치
    X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.

Device

Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.
  • 모델명 / 제조번호(시리얼번호)
    Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
  • 제품 설명
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • 제조사 주소
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • 제조사 모회사 (2017)
    X-Spine Systems, Inc
  • Source
    USFDA