Events

Device Recall Implant Holder for SynFixLR 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
    56343
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2583-2010
  • 사례 시작날짜
    2010-07-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93275
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • 원인
    A potential for the implant holder tip to break off and lodge in the synfix-lr implant, which pose a potential risk to the patient.
  • 조치
    Synthes Spine Hospital sent an ' URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated August 20, 2010 to all customers. The letter described the labeling issue and actions to be taken by the customers. The customers were instructed to review the supplementary labeling provided; contact their Synthes Spine Sales Consultant to arrange for provision of the Holding Forceps (p/n 388.401) prior to each SynFix-LR procedure; and complete and return the enclosed Verification Section form to Synthes via fax at 610-251-9005 or email: FieldAction@Synthes.com. If you have any questions, please call 1-800-620-7025 x 3500 or contact your Synthes Spine Sales Consultant.

Device

Device Recall Implant Holder for SynFixLR
  • 모델명 / 제조번호(시리얼번호)
    Catolog Number: 03.802.039 - all lot numbers
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: USA and the countries of Canada, Japan, Switzerland, Australia, Mexico, Malaysia, New Zealand, and Singapore.
  • 제품 설명
    SynFix-LR Spinal Implant System (Implant Holder for SynFix-LR and surgical technique brochure) || The implant holder is used to place the implant into the vertebral disc space.
  • 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