Events

Device Recall NFix II System 150mm 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA (HQ), 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
    56323
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2346-2010
  • 사례 시작날짜
    2009-02-09
  • 사례 출판 날짜
    2010-09-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93232
  • 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
    posterior metal/polymer spinal system, fusion - Product Code NQP
  • 원인
    Package integrity compromised.
  • 조치
    The firm, SYNTHES, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 9, 2009 and an updated letter dated February 12, 2009, with updated expiration information to customers. The letters described the product, problem and action to be taken by customer. The customers were instructed to call Synthes at 1-800-479-6329 if they have any of the identified devices to obtain a Return Authorization Number; complete the enclosed Verification Section attachment and return this letter with the recalled product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If they do not have the identified product ,complete the Verification Section attachment and return the document to Synthes by Fax 610-719-5120 or scan/email: lewis.lynne@synthes.com. If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.

Device

Device Recall NFix II System 150mm
  • 모델명 / 제조번호(시리얼번호)
    Catalog number NX60150-1. Lot numbers P06J01, P06J02, P06M01, P06M02, P07D02, P07H01, P07J01, and P07G01
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.
  • 제품 설명
    NFix II System 150mm || The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
  • Manufacturer
    Synthes USA (HQ), Inc.

Manufacturer

Synthes USA (HQ), Inc.
  • 제조사 주소
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA