Events

Device Recall Vanguard XP Knee System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 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
    73400
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1265-2016
  • 사례 시작날짜
    2016-02-05
  • 사례 출판 날짜
    2016-03-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144063
  • 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, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • 원인
    The anterior/posterior (ap) dimension may be oversized by 0.016. if the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. a revision surgery may be necessary.
  • 조치
    On 2/5/2016, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. 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. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Device

Device Recall Vanguard XP Knee System
  • 모델명 / 제조번호(시리얼번호)
    Part number; Description; Lot number  195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929 Vanguard XP Porous Femoral Rt 52.5 727260 195929 Vanguard XP Porous Femoral Rt 52.5 727280 195930 Vanguard XP Porous Femoral Rt 55 054980 195930 Vanguard XP Porous Femoral Rt 55 727270 195930 Vanguard XP Porous Femoral Rt 55 727290 195930 Vanguard XP Porous Femoral Rt 55 727310 195930 Vanguard XP Porous Femoral Rt 55 886090 195930 Vanguard XP Porous Femoral Rt 55 961570 195930 Vanguard XP Porous Femoral Rt 55 961580 195931 Vanguard XP Porous Femoral Rt 57.5 054700 195931 Vanguard XP Porous Femoral Rt 57.5 054760 195931 Vanguard XP Porous Femoral Rt 57.5 054990 195931 Vanguard XP Porous Femoral Rt 57.5 055340 195931 Vanguard XP Porous Femoral Rt 57.5 105720 195931 Vanguard XP Porous Femoral Rt 57.5 105730 195931 Vanguard XP Porous Femoral Rt 57.5 105830 195931 Vanguard XP Porous Femoral Rt 57.5 624770 195931 Vanguard XP Porous Femoral Rt 57.5 624940 195932 Vanguard XP Porous Femoral Rt 60 054770 195932 Vanguard XP Porous Femoral Rt 60 054780 195932 Vanguard XP Porous Femoral Rt 60 055000 195932 Vanguard XP Porous Femoral Rt 60 055160 195932 Vanguard XP Porous Femoral Rt 60 105840 195932 Vanguard XP Porous Femoral Rt 60 519250 195932 Vanguard XP Porous Femoral Rt 60 624780 195932 Vanguard XP Porous Femoral Rt 60 624950 195932 Vanguard XP Porous Femoral Rt 60 624960 195932 Vanguard XP Porous Femoral Rt 60 961610 195932 Vanguard XP Porous Femoral Rt 60 961620 195932 Vanguard XP Porous Femoral Rt 60 996930 195933 Vanguard XP Porous Femoral Rt 62.5 054600 195933 Vanguard XP Porous Femoral Rt 62.5 054790 195933 Vanguard XP Porous Femoral Rt 62.5 055010 195933 Vanguard XP Porous Femoral Rt 62.5 055170 195933 Vanguard XP Porous Femoral Rt 62.5 055350 195933 Vanguard XP Porous Femoral Rt 62.5 105850 195933 Vanguard XP Porous Femoral Rt 62.5 519260 195933 Vanguard XP Porous Femoral Rt 62.5 624790 195933 Vanguard XP Porous Femoral Rt 62.5 624970 195933 Vanguard XP Porous Femoral Rt 62.5 961630 195933 Vanguard XP Porous Femoral Rt 62.5 961640 195934 Vanguard XP Porous Femoral Rt 65 054610 195934 Vanguard XP Porous Femoral Rt 65 054800 195934 Vanguard XP Porous Femoral Rt 65 055020 195934 Vanguard XP Porous Femoral Rt 65 055180 195934 Vanguard XP Porous Femoral Rt 65 055360 195934 Vanguard XP Porous Femoral Rt 65 105740 195934 Vanguard XP Porous Femoral Rt 65 105750 195934 Vanguard XP Porous Femoral Rt 65 105870 195934 Vanguard XP Porous Femoral Rt 65 519270 195934 Vanguard XP Porous Femoral Rt 65 624670 195934 Vanguard XP Porous Femoral Rt 65 624800 195934 Vanguard XP Porous Femoral Rt 65 624980 195935 Vanguard XP Porous Femoral Rt 67.5 054620 195935 Vanguard XP Porous Femoral Rt 67.5 054810 195935 Vanguard XP Porous Femoral Rt 67.5 055030 195935 Vanguard XP Porous Femoral Rt 67.5 055190 195935 Vanguard XP Porous Femoral Rt 67.5 055370 195935 Vanguard XP Porous Femoral Rt 67.5 064660 195935 Vanguard XP Porous Femoral Rt 67.5 105880 195935 Vanguard XP Porous Femoral Rt 67.5 519280 195935 Vanguard XP Porous Femoral Rt 67.5 624680 195935 Vanguard XP Porous Femoral Rt 67.5 624810 195935 Vanguard XP Porous Femoral Rt 67.5 624990 195935 Vanguard XP Porous Femoral Rt 67.5 961670 195935 Vanguard XP Porous Femoral Rt 67.5 961680 195936 Vanguard XP Porous Femoral Rt 70 054630 195936 Vanguard XP Porous Femoral Rt 70 054830 195936 Vanguard XP Porous Femoral Rt 70 055040 195936 Vanguard XP Porous Femoral Rt 70 055200 195936 Vanguard XP Porous Femoral Rt 70 055380 195936 Vanguard XP Porous Femoral Rt 70 105890 195936 Vanguard XP Porous Femoral Rt 70 519290 195936 Vanguard XP Porous Femoral Rt 70 624690 195936 Vanguard XP Porous Femoral Rt 70 624820 195936 Vanguard XP Porous Femoral Rt 70 625000 195936 Vanguard XP Porous Femoral Rt 70 961690 195936 Vanguard XP Porous Femoral Rt 70 961700 195937 Vanguard XP Porous Femoral Rt 72.5 054710 195937 Vanguard XP Porous Femoral Rt 72.5 054840 195937 Vanguard XP Porous Femoral Rt 72.5 055050 195937 Vanguard XP Porous Femoral Rt 72.5 055390 195937 Vanguard XP Porous Femoral Rt 72.5 105900 195937 Vanguard XP Porous Femoral Rt 72.5 624830 195937 Vanguard XP Porous Femoral Rt 72.5 625010 195937 Vanguard XP Porous Femoral Rt 72.5 961710 195937 Vanguard XP Porous Femoral Rt 72.5 961720 195938 Vanguard XP Porous Femoral Rt 75 054850 195938 Vanguard XP Porous Femoral Rt 75 286570 195938 Vanguard XP Porous Femoral Rt 75 519300 195938 Vanguard XP Porous Femoral Rt 75 625020 195938 Vanguard XP Porous Femoral Rt 75 627250 195938 Vanguard XP Porous Femoral Rt 75 961730 195938 Vanguard XP Porous Femoral Rt 75 961740 195938 Vanguard XP Porous Femoral Rt 75 996940 195939 Vanguard XP Porous Femoral Rt 77.5 054720 195939 Vanguard XP Porous Femoral Rt 77.5 055060 195939 Vanguard XP Porous Femoral Rt 77.5 105760 195939 Vanguard XP Porous Femoral Rt 77.5 105910 195939 Vanguard XP Porous Femoral Rt 77.5 273560 195939 Vanguard XP Porous Femoral Rt 77.5 510290 195939 Vanguard XP Porous Femoral Rt 77.5 519310 195940 Vanguard XP Porous Femoral Rt 80 054870 195940 Vanguard XP Porous Femoral Rt 80 055220 195940 Vanguard XP Porous Femoral Rt 80 519320 195940 Vanguard XP Porous Femoral Rt 80 625030 195940 Vanguard XP Porous Femoral Rt 80 961750 195940 Vanguard XP Porous Femoral Rt 80 961760 195940 Vanguard XP Porous Femoral Rt 80 996890 195941 Vanguard XP Porous Femoral Lt 52.5 054880 195941 Vanguard XP Porous Femoral Lt 52.5 055230 195941 Vanguard XP Porous Femoral Lt 52.5 299130 195941 Vanguard XP Porous Femoral Lt 52.5 510240 195941 Vanguard XP Porous Femoral Lt 52.5 625040 195941 Vanguard XP Porous Femoral Lt 52.5 961770 195941 Vanguard XP Porous Femoral Lt 52.5 961780 195941 Vanguard XP Porous Femoral Lt 52.5 996950 195942 Vanguard XP Porous Femoral Lt 55 054730 195942 Vanguard XP Porous Femoral Lt 55 054890 195942 Vanguard XP Porous Femoral Lt 55 055080 195942 Vanguard XP Porous Femoral Lt 55 055400 195942 Vanguard XP Porous Femoral Lt 55 105920 195942 Vanguard XP Porous Femoral Lt 55 236410 195942 Vanguard XP Porous Femoral Lt 55 455200 195942 Vanguard XP Porous Femoral Lt 55 625050 195942 Vanguard XP Porous Femoral Lt 55 961790 195942 Vanguard XP Porous Femoral Lt 55 961800 195943 Vanguard XP Porous Femoral Lt 57.5 054640 195943 Vanguard XP Porous Femoral Lt 57.5 054900 195943 Vanguard XP Porous Femoral Lt 57.5 055090 195943 Vanguard XP Porous Femoral Lt 57.5 055250 195943 Vanguard XP Porous Femoral Lt 57.5 055410 195943 Vanguard XP Porous Femoral Lt 57.5 398430 195943 Vanguard XP Porous Femoral Lt 57.5 519330 195943 Vanguard XP Porous Femoral Lt 57.5 624720 195943 Vanguard XP Porous Femoral Lt 57.5 624860 195943 Vanguard XP Porous Femoral Lt 57.5 625060 195943 Vanguard XP Porous Femoral Lt 57.5 642950 195943 Vanguard XP Porous Femoral Lt 57.5 996870 195943 Vanguard XP Porous Femoral Lt 57.5 996880 195943 Vanguard XP Porous Femoral Lt 57.5 996900 195944 Vanguard XP Porous Femoral Lt 60 054650 195944 Vanguard XP Porous Femoral Lt 60 054910 195944 Vanguard XP Porous Femoral Lt 60 055100 195944 Vanguard XP Porous Femoral Lt 60 055270 195944 Vanguard XP Porous Femoral Lt 60 055420 195944 Vanguard XP Porous Femoral Lt 60 106050 195944 Vanguard XP Porous Femoral Lt 60 519340 195944 Vanguard XP Porous Femoral Lt 60 624730 195944 Vanguard XP Porous Femoral Lt 60 624870 195944 Vanguard XP Porous Femoral Lt 60 625070 195944 Vanguard XP Porous Femoral Lt 60 961810 195944 Vanguard XP Porous Femoral Lt 60 961820 195945 Vanguard XP Porous Femoral Lt 62.5 054670 195945 Vanguard XP Porous Femoral Lt 62.5 054920 195945 Vanguard XP Porous Femoral Lt 62.5 055110 195945 Vanguard XP Porous Femoral Lt 62.5 055280 195945 Vanguard XP Porous Femoral Lt 62.5 055430 195945 Vanguard XP Porous Femoral Lt 62.5 105930 195945 Vanguard XP Porous Femoral Lt 62.5 519350 195945 Vanguard XP Porous Femoral Lt 62.5 624880 195945 Vanguard XP Porous Femoral Lt 62.5 624890 195945 Vanguard XP Porous Femoral Lt 62.5 625080 195945 Vanguard XP Porous Femoral Lt 62.5 961840 195945 Vanguard XP Porous Femoral Lt 62.5 961850 195946 Vanguard XP Porous Femoral Lt 65 054680 195946 Vanguard XP Porous Femoral Lt 65 054930 195946 Vanguard XP Porous Femoral Lt 65 055130 195946 Vanguard XP Porous Femoral Lt 65 055290 195946 Vanguard XP Porous Femoral Lt 65 055440 195946 Vanguard XP Porous Femoral Lt 65 105940 195946 Vanguard XP Porous Femoral Lt 65 510780 195946 Vanguard XP Porous Femoral Lt 65 519360 195946 Vanguard XP Porous Femoral Lt 65 624740 195946 Vanguard XP Porous Femoral Lt 65 624910 195946 Vanguard XP Porous Femoral Lt 65 625100 195946 Vanguard XP Porous Femoral Lt 65 961860 195946 Vanguard XP Porous Femoral Lt 65 961870 195947 Vanguard XP Porous Femoral Lt 67.5 054690 195947 Vanguard XP Porous Femoral Lt 67.5 054860 195947 Vanguard XP Porous Femoral Lt 67.5 054940 195947 Vanguard XP Porous Femoral Lt 67.5 055140 195947 Vanguard XP Porous Femoral Lt 67.5 055300 195947 Vanguard XP Porous Femoral Lt 67.5 105950 195947 Vanguard XP Porous Femoral Lt 67.5 519370 195947 Vanguard XP Porous Femoral Lt 67.5 624750 195947 Vanguard XP Porous Femoral Lt 67.5 624920 195947 Vanguard XP Porous Femoral Lt 67.5 625110 195947 Vanguard XP Porous Femoral Lt 67.5 961880 195947 Vanguard XP Porous Femoral Lt 67.5 961890 195948 Vanguard XP Porous Femoral Lt 70 054740 195948 Vanguard XP Porous Femoral Lt 70 054950 195948 Vanguard XP Porous Femoral Lt 70 055120 195948 Vanguard XP Porous Femoral Lt 70 055450 195948 Vanguard XP Porous Femoral Lt 70 105960 195948 Vanguard XP Porous Femoral Lt 70 624760 195948 Vanguard XP Porous Femoral Lt 70 624930 195948 Vanguard XP Porous Femoral Lt 70 625120 195948 Vanguard XP Porous Femoral Lt 70 961900 195948 Vanguard XP Porous Femoral Lt 70 961910 195949 Vanguard XP Porous Femoral Lt 72.5 054960 195949 Vanguard XP Porous Femoral Lt 72.5 055310 195949 Vanguard XP Porous Femoral Lt 72.5 519380 195949 Vanguard XP Porous Femoral Lt 72.5 625130 195949 Vanguard XP Porous Femoral Lt 72.5 961920 195949 Vanguard XP Porous Femoral Lt 72.5 961930 195949 Vanguard XP Porous Femoral Lt 72.5 996960 195950 Vanguard XP Porous Femoral Lt 75 054970 195950 Vanguard XP Porous Femoral Lt 75 055320 195950 Vanguard XP Porous Femoral Lt 75 625140 195950 Vanguard XP Porous Femoral Lt 75 961940 195950 Vanguard XP Porous Femoral Lt 75 961950 195950 Vanguard XP Porous Femoral Lt 75 996910 195951 Vanguard XP Porous Femoral Lt 77.5 054750 195951 Vanguard XP Porous Femoral Lt 77.5 519390 195951 Vanguard XP Porous Femoral Lt 77.5 673550 195951 Vanguard XP Porous Femoral Lt 77.5 961960 195951 Vanguard XP Porous Femoral Lt 77.5 961970 195952 Vanguard XP Porous Femoral Lt 80 055150 195952 Vanguard XP Porous Femoral Lt 80 105770 195952 Vanguard XP Porous Femoral Lt 80 273530 195952 Vanguard XP Porous Femoral Lt 80 996920
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    UT Netherlands
  • 제품 설명
    Vanguard XP Knee System Porous Femoral Component || various sizes and orientation a total knee replacement system. || prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, || coated, polymer/metal/polymer
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • 제조사 주소
    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