Events

Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer, 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
    68457
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1934-2014
  • 사례 시작날짜
    2014-05-19
  • 사례 출판 날짜
    2014-06-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127984
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
  • 조치
    Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.

Device

Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208 61488209 61488210 61488211 61518162 61518163 61518164 61526401 61538046 61543975 61543976 61558363 61567340 61567341 61567342 61567343 61592088 61592089 61627203 61627204 61627205 61627206 61643933 61643934 61658878 61658879 61658880 61658881 61658882 61678232 61678233 61682153 61682154 61682155 61692238 61692240 61721671 61721672 61721673 61774143 61774144 61774145 61774146 61774147 61774148 61827117 61827118 61827119 61863112 61863113 61863114 61863115 61863116 61912438 61914866 61914867 61914868 61914869 61934684 61934685 61934686 61934687 61958859 61958860 61958861 61979028 61979029 61979030 62016156 62016157 62016158 62022554 62022555 62029928 62029929 62029930 62041303 62041304 62060613 62060614 62064935 62064936 62077849 62077850 62077851 62143194 62143195 62143196 62143197 62143604 62143605 62143606 62143607 62168183 62168184 62193304 62193305 62193306 62200285 62200286 62214670 62214671 62214672 62227418 62227419 62261960 62261961 62261962 62261963 62261964 62261966 62315724 62319295 62319296 62319297 62326311 62326312 62332564 62332565 62345558 62345559 62358488 62358490 62363649 62377650 62383363 62383364 62390066 62390067 62390068 62454576 62454577 62454578 62465724 62465725 62465726 62473212 62473213 62473215 62528582 62528583 62586506 62586507 62586509 62586510 62586518 62610915 62610916 62640976 62640977 62640978 62640979 62646146 62646147 62649656 62649658
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA