Events

Device Recall Solanas Posterior Stabilization System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alphatec Spine, 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
    59920
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0932-2012
  • 사례 시작날짜
    2010-11-01
  • 사례 출판 날짜
    2012-01-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104000
  • 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
    These lots were not manufactured correctly in that the instrument does not have the durability required to repeatedly perform over its full service life and, therefore, may experience breakage in the tips.
  • 조치
    Alphatec Spine contacted all affected customers via telephone. The communication included discussion of the product, problem, and actions to be taken by the customers. Customers were instructed to remove the affected product from inventory and to return the product to the firm. Arrangements were made for replacement product to be sent to the customers. Contact the firm at 1-800-922-1356 for questions regarding this recall.

Device

Device Recall Solanas Posterior Stabilization System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 608227B, 609867B, 609870B, 609882B, 609897B, 609971B
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-including the states of CA, CT, FL, GA, NC, NE, NJ, TX, and UT.
  • 제품 설명
    Solanas Posterior Stabilization System Part Number: 63920. || Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
    Alphatec Holdings Inc.
  • Source
    USFDA