Events

Device Recall SLift Implant Guides 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 SpineFrontier, 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
    63075
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0417-2013
  • 사례 시작날짜
    2012-08-22
  • 사례 출판 날짜
    2012-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112475
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 원인
    When using the optional s-lift (also known as s-lif) implant guides without stops, there is a known risk of moving the implant guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. the instructions for use for the s-lift implant guides will be amended to add the following warning: "care is to be taken to not over insert the implant guides.
  • 조치
    Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.

Device

Device Recall SLift Implant Guides
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 012064-001
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide including the states of: MA and TX.
  • 제품 설명
    S-Lift Implant Guides (also known as S-LIF) || Compressor Part Number: 11-50223 || Product Usage: || Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • 제조사 주소
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • 제조사 모회사 (2017)
    SpineFrontier, Inc.
  • Source
    USFDA