Events

Device Recall ATN 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
    79408
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1235-2018
  • 사례 시작날짜
    2017-12-20
  • 사례 출판 날짜
    2018-03-14
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162250
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 원인
    Zimmer biomet is conducting a medical device recall for the ace trochanteric nail (atn) system after a device performance review (dpr) failed clinical analysis for survivorship pursuant to the acceptance criteria for the dpr protocol for the atn system.
  • 조치
    On December 22, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers with a complete list of products subject to recall and requesting that the customer review the notification and notify all affected personnel of the recall. If there is affected product at the facility it is requested that these units be quarantined and returned to a sales representative for return to the firm. Questions or concerns can be directed to 574-371-3071.

Device

Device Recall ATN System
  • 모델명 / 제조번호(시리얼번호)
    915209320 915209340 915209360 915209380 915209400 915209420 915209440 915209460 915211320 915211340 915211360 915211380 915211400 915211420 915211440 915211460 915213320 915213340 915213360 915213380 915213400 915213420 915213440 915213460 916209320 916209340 916209360 916209380 916209400 916209420 916209440 916209460 916211320 916211340 916211360 916211380 916211400 916211420 916211440 916211460 916213320 916213340 916213360 916213380 916213400 916213420 916213440 916213460 925200320 925209320 925209340 925209360 925209380 925209400 925209420 925209440 925209460 925211340 925211360 925211380 925211400 925211420 925211440 925211460 925213320 925213340 925213360 925213380 925213400 925213420 925213440 925213460 926209320 926209340 926209360 926209380 926209400 926209420 926209440 926209460 926211320 926211340 926211360 926211380 926211400 926211420 926211440 926213320 926213340 926213360 926213380 926213400 926213420 926213440 926213460 935209320 935209340 935209360 935209380 935209400 935209420 935209440 935209460 935211320 935211340 935211360 935211380 935211400 935211420 935211440 935211460 935213320 935213340 935213360 935213380 935213400 935213420 935213440 935213460 936213320 936213340 936213360 936213380 936213400 936213420 936213440 936213460 936309320 936309340 936309360 936309380 936309400 936309420 936309440 936309460 936311320 936311340 936311360 936311380 936311400 936311420 936311440 936311460
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA (nationwide)
  • 제품 설명
    ACE Trochanteric Nail System || STER L H TROC NAIL 320X9X125 || STER L H TROC NAIL 340X9X125 || STER L H TROC NAIL 360X9X125 || STER L H TROC NAIL 380X9X125 || STER L H TROC NAIL 400X9X125 || STER L H TROC NAIL 420X9X125 || STER L H TROC NAIL 440X9X125 || STER L H TROC NAIL 460X9X125 || STER L H TROC NAIL 320X11X125 || STER L H TROC NAIL 340X11X125 || STER L H TROC NAIL 360X11X125 || STER L H TROC NAIL 380X11X125 || STER L H TROC NAIL 400X11X125 || STER L H TROC NAIL 420X11X125 || STER L H TROC NAIL 440X11X125 || STER L H TROC NAIL 460X11X125 || STER L H TROC NAIL 320X13X125 || STER L H TROC NAIL 340X13X125 || STER L H TROC NAIL 360X13X125 || STER L H TROC NAIL 380X13X125 || STER L H TROC NAIL 400X13X125 || STER L H TROC NAIL 420X13X125 || STER L H TROC NAIL 440X13X125 || STER L H TROC NAIL 460X13X125 || STER R H TROC NAIL 320X9X125 || STER R H TROC NAIL 340X9X125 || STER R H TROC NAIL 360X9X125 || STER R H TROC NAIL 380X9X125 || STER R H TROC NAIL 400X9X125 || STER R H TROC NAIL 420X9X125 || STER R H TROC NAIL 440X9X125 || STER R H TROC NAIL 460X9X125 || STER R H TROC NAIL 320X11X125 || STER R H TROC NAIL 340X11X125 || STER R H TROC NAIL 360X11X125 || STER R H TROC NAIL 380X11X125 || STER R H TROC NAIL 400X11X125 || STER R H TROC NAIL 420X11X125 || STER R H TROC NAIL 440X11X125 || STER R H TROC NAIL 460X11X125 || STER R H TROC NAIL 320X13X125 || STER R H TROC NAIL 340X13X125 || STER R H TROC NAIL 360X13X125 || STER R H TROC NAIL 380X13X125 || STER R H TROC NAIL 400X13X125 || STER R H TROC NAIL 420X13X125 || STER R H TROC NAIL 440X13X125 || STER R H TROC NAIL 460X13X125 || STER L H TROC NAIL 320X11X130 || STER L H TROC NAIL 320X9X130 || STER L H TROC NAIL 340X9X130 || STER L H TROC NAIL 360X9X130 || STER L H TROC NAIL 380X9X130 || STER L H TROC NAIL 400X9X130 || STER L H TROC NAIL 420X9X130 || STER L H TROC NAIL 440X9X130 || STER L H TROC NAIL 460X9X130 || STER L H TROC NAIL 340X11X130 || STER L H TROC NAIL 360X11X130 || STER L H TROC NAIL 380X11X130 || STER L H TROC NAIL 400X11X130 || STER L H TROC NAIL 420X11X130 || STER L H TROC NAIL 440X11X130 || STER L H TROC NAIL 460X11X130 || STER L H TROC NAIL 320X13X130 || STER L H TROC NAIL 340X13X130 || STER L H TROC NAIL 360X13X130 || STER L H TROC NAIL 380X13X130 || STER L H TROC NAIL 400X13X130 || STER L H TROC NAIL 420X13X130 || STER L H TROC NAIL 440X13X130 || STER L H TROC NAIL 460X13X130 || STER R H TROC NAIL 320X9X130 || STER R H TROC NAIL 340X9X130 || STER R H TROC NAIL 360X9X130 || STER R H TROC NAIL 380X9X130 || STER R H TROC NAIL 400X9X130 || STER R H TROC NAIL 420X9X130 || STER R H TROC NAIL 440X9X130 || STER R H TROC NAIL 460X9X130 || STER R H TROC NAIL 320X11X130 || STER R H TROC NAIL 340X11X130 || STER R H TROC NAIL 360X11X130 || STER R H TROC NAIL 380X11X130 || STER R H TROC NAIL 400X11X130 || STER R H TROC NAIL 420X11X130 || STER R H TROC NAIL 440X11X130 || STER R H TROC NAIL 320X13X130 || STER R H TROC NAIL 340X13X130 || STER R H TROC NAIL 360X13X130 || STER R H TROC NAIL 380X13X130 || STER R H TROC NAIL 400X13X130 || STER R H TROC NAIL 420X13X130 || STER R H TROC NAIL 440X13X130 || STER R H TROC NAIL 460X13X130 || STER L H TROC NAIL 320X9X135 || STER L H TROC NAIL 340X9X135 || STER L H TROC NAIL 360X9X135 || STER L H TROC NAIL 380X9X135 || STER L H TROC NAIL 400X9X135 || STER L H TROC NAIL 420X9X135 || STER L H TROC NAIL 440X9X135 || STER L H TROC NAIL 460X9X135 || STER L H TROC NAIL 320X11X135 || STER L H TROC NAIL 340X11X135 || STER L H TROC NAIL 360X11X135 || STER L H TROC NAIL 380X11X135 || STER L H TROC NAIL 400X11X135 || STER L H TROC NAIL 420X11X135 || STER L H TROC NAIL 440X11X135 || STER L H TROC NAIL 460X11X135 || STER L H TROC NAIL 320X13X135 || STER L H TROC NAIL 340X13X135 || STER L H TROC NAIL 360X13X135 || STER L H TROC NAIL 380X13X135 || STER L H TROC NAIL 400X13X135 || STER L H TROC NAIL 420X13X135 || STER L H TROC NAIL 440X13X135 || STER L H TROC NAIL 460X13X135 || STER R H TROC NAIL 320X13X135 || STER R H TROC NAIL 340X13X135 || STER R H TROC NAIL 360X13X135 || STER R H TROC NAIL 380X13X135 || STER R H TROC NAIL 400X13X135 || STER R H TROC NAIL 420X13X135 || STER R H TROC NAIL 440X13X135 || STER R H TROC NAIL 460X13X135 || STER R H TROC NAIL 320X9X135 || STER R H TROC NAIL 340X9X135 || STER R H TROC
  • 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