Events

Device Recall AIM/ART (ACE Retrograde Tibial Nail) 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
    79409
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1197-2018
  • 사례 시작날짜
    2018-02-06
  • 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=162238
  • 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
    The aim tibial nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the device performance review protocol for the implant system.
  • 조치
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 06, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove it from your facility. 3. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents.2. Quarantine affected product in your inventory. 3.Return affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. International returns, request an International Return Authorization (IRA) Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

Device Recall AIM/ART (ACE Retrograde Tibial Nail) System
  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US of Indiana and country of the Republic of Korea.
  • 제품 설명
    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 || 810508270 NAIL TIB DYN 08 X 27.0 || 810508285 NAIL TIB DYN 08 X 28.5 || 810508300 NAIL TIB DYN 08 X 30.0 || 810508315 NAIL TIB DYN 08 X 31.5 || 810508330 NAIL TIB DYN 08 X 33.0 || 810508345 NAIL TIB DYN 08 X 34.5 || 810508360 NAIL TIB DYN 08 X 36.0 || 810508375 NAIL TIB DYN 08 X 37.5 || 810508390 NAIL TIB DYN 08 X 39.0 || 810508405 NAIL TIB DYN 08 X 40.5 || 810508420 NAIL TIB DYN 08 X 42.0 || 810509255 NAIL TIB DYN 09 X 25.5 || 810509270 NAIL TIB DYN 09 X 27.0 || 810509285 NAIL TIB DYN 09 X 28.5 || 810509300 NAIL TIB DYN 09 X 30.0 || 810509315 NAIL TIB DYN 09 X 31.5 || 810509330 NAIL TIB DYN 09 X 33.0 || 810509345 NAIL TIB DYN 09 X 34.5 || 810509360 NAIL TIB DYN 09 X 36.0 || 810509375 NAIL TIB DYN 09 X 37.5 || 810509390 NAIL TIB DYN 09 X 39.0 || 810509405 NAIL TIB DYN 09 X 40.5 || 810509420 NAIL TIB DYN 09 X 42.0 || 810510255 NAIL TIB DYN 10 X 25.5 || 810510270 NAIL TIB DYN 10 X 27.0 || 810510285 NAIL TIB DYN 10 X 28.5 || 810510300 NAIL TIB DYN 10 X 30.0 || 810510315 NAIL TIB DYN 10 X 31.5 || 810510330 NAIL TIB DYN 10 X 33.0 || 810510345 NAIL TIB DYN 10 X 34.5 || 810510360 NAIL TIB DYN 10 X 36.0 || 810510375 NAIL TIB DYN 10 X 37.5 || 810510390 NAIL TIB DYN 10 X 39.0 || 810510405 NAIL TIB DYN 10 X 40.5 || 810510420 NAIL TIB DYN 10 X 42.0 || 810511255 NAIL TIB DYN 11 X 25.5 || 810511270 NAIL TIB DYN 11 X 27.0 || 810511285 NAIL TIB DYN 11 X 28.5 || 810511300 NAIL TIB DYN 11 X 30.0 || 810511315 NAIL TIB DYN 11 X 31.5 || 810511330 NAIL TIB DYN 11 X 33.0 || 810511345 NAIL TIB DYN 11 X 34.5 || 810511360 NAIL TIB DYN 11 X 36.0 || 810511375 NAIL TIB DYN 11 X 37.5 || 810511390 NAIL TIB DYN 11 X 39.0 || 810511405 NAIL TIB DYN 11 X 40.5 || 810511420 NAIL TIB DYN 11 X 42.0 || 810512270 NAIL TIB DYN 12 X 27.0 || 810512285 NAIL TIB DYN 12 X 28.5 || 810512300 NAIL TIB DYN 12 X 30.0 || 810512315 NAIL TIB DYN 12 X 31.5 || 810512330 NAIL TIB DYN 12 X 33.0 || 810512345 NAIL TIB DYN 12 X 34.5 || 810512360 NAIL TIB DYN 12 X 36.0 || 810512375 NAIL TIB DYN 12 X 37.5 || 810512390 NAIL TIB DYN 12 X 39.0 || 810512405 NAIL TIB DYN 12 X 40.5 || 810512420 NAIL TIB DYN 12 X 42.0 || 810513255 NAIL TIB DYN 13 X 25.5 || 810513285 NAIL TIB DYN 13MM X 28.5CM || 810513300 NAIL TIB DYN 13MMX30.0 CM || 810513315 NAIL TIB DYN 13MM X 31.5 CM || 810513330 NAIL TIB DYN 13 X 33.0 || 810513345 NAIL TIB DYN 13MM X 34.5 CM || 810513360 NAIL TIB DYN 13 X 36.0 MM || 810513375 NAIL TIB DYN 13MM X 37.5 CM || 810513390 NAIL TIB DYN 13MMX39.0CM || 810513405 NAIL TIB DYN 13MM X 40.5 CM || 810513420 NAIL TIB DYN 13MM X 42 CM || Product Usage: || A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
  • 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