Events

Vanguard 360 Revision Knee System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    75235
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0003-2017
  • 사례 시작날짜
    2016-08-08
  • 사례 출판 날짜
    2016-10-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149732
  • 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
    The drill bit used to drill the hex pre-drilled hole in the screw head of the tibial augment bolts included in the vanguard 360 revision knee system was larger than allowable per the process specification. as a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. the bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. this possible event can result in an intraoperative delay resulting in increased time under anesthesia.
  • 조치
    Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL REMOVAL notifications dated August 8, 2016, to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com. For further questions, please call (800) 348-2759.

Device

Vanguard 360 Revision Knee System
  • 모델명 / 제조번호(시리얼번호)
    ITEM LOT DESCRIPTION 185220 262690 BMT 360 TIB AUG 59X5MM 185221 475560 BMT 360 TIB AUG 63X5MM 185222 262720 BMT 360 TIB AUG 67X5MM 185222 475570 BMT 360 TIB AUG 67X5MM 185222 524160 BMT 360 TIB AUG 67X5MM 185222 690770 BMT 360 TIB AUG 67X5MM 185223 421690 BMT 360 TIB AUG 71X5MM 185223 475580 BMT 360 TIB AUG 71X5MM 185223 475590 BMT 360 TIB AUG 71X5MM 185223 524170 BMT 360 TIB AUG 71X5MM 185224 475600 BMT 360 TIB AUG 75X5MM 185224 475610 BMT 360 TIB AUG 75X5MM 185224 524180 BMT 360 TIB AUG 75X5MM 185224 647840 BMT 360 TIB AUG 75X5MM 185224 690790 BMT 360 TIB AUG 75X5MM 185225 342740 BMT 360 TIB AUG 79X5MM 185225 421700 BMT 360 TIB AUG 79X5MM 185225 524190 BMT 360 TIB AUG 79X5MM 185225 524200 BMT 360 TIB AUG 79X5MM 185225 690800 BMT 360 TIB AUG 79X5MM 185226 647850 BMT 360 TIB AUG 83X5MM 185226 751570 BMT 360 TIB AUG 83X5MM 185228 647910 BMT 360 TIB AUG 91X5MM 185228 751420 BMT 360 TIB AUG 91X5MM 185230 524210 BMT 360 TIB AUG 59X10MM 185231 421730 BMT 360 TIB AUG 63X10MM 185231 475620 BMT 360 TIB AUG 63X10MM 185231 524220 BMT 360 TIB AUG 63X10MM 185232 377450 BMT 360 TIB AUG 67X10MM 185232 377460 BMT 360 TIB AUG 67X10MM 185232 421750 BMT 360 TIB AUG 67X10MM 185232 475630 BMT 360 TIB AUG 67X10MM 185232 524230 BMT 360 TIB AUG 67X10MM 185233 342750 BMT 360 TIB AUG 71X10MM 185233 377470 BMT 360 TIB AUG 71X10MM 185233 475640 BMT 360 TIB AUG 71X10MM 185233 524240 BMT 360 TIB AUG 71X10MM 185234 262780 BMT 360 TIB AUG 75X10MM 185234 262790 BMT 360 TIB AUG 75X10MM 185234 524250 BMT 360 TIB AUG 75X10MM 185235 421770 BMT 360 TIB AUG 79X10MM 185235 421780 BMT 360 TIB AUG 79X10MM 185237 229750 BMT 360 TIB AUG 87X10MM 185238 229760 BMT 360 TIB AUG 91X10MM 185238 262820 BMT 360 TIB AUG 91X10MM 185239 511390 BMT 360 TIB AUG BOLT 10MM 185241 148190 BMT 360 TIB AUG 63X15MM RL/LM 185242 969710 BMT 360 TIB AUG 67X15MM RL/LM 185243 377480 BMT 360 TIB AUG 71X15MM RL/LM 185247 262750 BMT 360 TIB AUG 87X15 RL/LM 185250 421790 BMT 360 TIB AUG 59X15MM LL/RM 185251 262770 BMT 360 TIB AUG 63X15MM LL/RM 185253 421800 BMT 360 TIB AUG 71X15MM LL/RM 185254 229770 BMT 360 TIB AUG 75X15MM LL/RM 185255 229780 BMT 360 TIB AUG 79X15MM LL/RM 185256 988680 BMT 360 TIB AUG 83X15MM LL/RM 185257 148210 BMT 360 TIB AUG 87X15 LL/RM 185229-00 493640 BMT TIB AUG BOLT 5MM 185229-00 582090 BMT TIB AUG BOLT 5MM 185229-00 582100 BMT TIB AUG BOLT 5MM 185229-00 582110 BMT TIB AUG BOLT 5MM 185229-00 590570 BMT TIB AUG BOLT 5MM 185229-00 789260 BMT TIB AUG BOLT 5MM 185239-00 493690 BMT 360 TIB AUG BOLT 10MM 185239-00 590580 BMT 360 TIB AUG BOLT 10MM 185239-00 590590 BMT 360 TIB AUG BOLT 10MM 185239-00 590600 BMT 360 TIB AUG BOLT 10MM 185239-00 590610 BMT 360 TIB AUG BOLT 10MM 185239-00 590620 BMT 360 TIB AUG BOLT 10MM 185239-00 590630 BMT 360 TIB AUG BOLT 10MM 185239-00 666760 BMT 360 TIB AUG BOLT 10MM 185239-00 666780 BMT 360 TIB AUG BOLT 10MM
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.
  • 제품 설명
    Vanguard 360 Revision Knee System || Knee prostheses
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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