Events

Device Recall JustRight 5mm Stapler 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Justright Surgical, LLC 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
    71521
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1955-2015
  • 사례 시작날짜
    2015-06-11
  • 사례 출판 날짜
    2015-07-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138063
  • 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
    Staple, implantable - Product Code GDW
  • 원인
    Justright surgical is recalling various lots of justright 5mm stapler product because they may deliver incomplete staple formation and incomplete tissue closure.
  • 조치
    JustRight Surgical sent an Urgent Medical Device Recall letter dated June 12, 2015 to aaffected customers and distributor via an email. The letter identified the affected product, problem and actions to be taken. Custers were instructed Review, complete, and return the enclosed Acknowledgement Form directly to ¿Rep¿, your Sales Representative or email to orders@justrightsurgical.com or fax to (720) 287-7135. The following assistance is available: " For questions related to the issue or product replacement, please contact your local sales representative, ¿Rep¿, or contact JustRight Surgical Customer Service at (866) 683-1743, Monday through Friday from 7:30 AM to 5:00 PM MST. " For questions related to product pick-up by JustRight Surgical, please also contact your local sales representative or Customer Service (866) 683-1743. Return instructions are provided on the Acknowledgement Form. " For questions related to the Acknowledgement Form and its return, please contact the JustRight Surgical Director of Quality Systems at (720) 287-7146.

Device

Device Recall JustRight 5mm Stapler
  • 모델명 / 제조번호(시리얼번호)
    Model Number JR-ST25-2.0 Lot numbers 75ED0116, 75JD1404, 75KD0308, 75KD1216, 75LD0508, 75AE0709, 75AE2601, 75BE0506, 75BE2315, 75CE1630, 75CE2606, 75DE0102, and 75DE0804 (UK distribution).
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution - US Nationwide and Ireland.
  • 제품 설명
    JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. || Product Usage: || The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis.
  • Manufacturer
    Justright Surgical, LLC

Manufacturer

Justright Surgical, LLC
  • 제조사 주소
    Justright Surgical, LLC, 6325 Gunpark Dr, Suite G, Boulder CO 80301-3592
  • 제조사 모회사 (2017)
    JustRight Surgical LLC
  • Source
    USFDA