Events

Device Recall SLIFT Extension Shims 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
    65760
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0274-2014
  • 사례 시작날짜
    2013-08-28
  • 사례 출판 날짜
    2013-11-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120086
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Fit variation among all lots of s-lift extension shims with corresponding retractor blades. the firm's investigation revealed that extension shims may not fit down all retractor blades.
  • 조치
    SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.

Device

Device Recall SLIFT Extension Shims
  • 모델명 / 제조번호(시리얼번호)
    Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
  • 제품 설명
    S-LIFT Extension Shims || Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
  • 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