Events

Device Recall Repose G2 Bone Screw System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Xomed, 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
    52837
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0535-2010
  • 사례 시작날짜
    2009-07-27
  • 사례 출판 날짜
    2009-12-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-03-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84111
  • 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
    Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea - Product Code LRK
  • 원인
    Medtronic xomed, inc. is recalling the repose bone screw system product and bone screw product due to improper labeling. the labeling for the repose system was inadvertently placed on the repose screw and vice versa.
  • 조치
    Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist. 1. Fill-in the "quantity on-hand "column on the checklist. 2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE Field Action Contact Person for help to arrange for returns and replacements or credit. 3. Fax your Checklist to Medtronic ENT at the number provided. 4. Return products clearly marked.

Device

Device Recall Repose G2 Bone Screw System
  • 모델명 / 제조번호(시리얼번호)
    Lot # 62450300
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    9 consignees in the continental United States.
  • 제품 설명
    Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. || Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. || The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • 제조사 주소
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA