Events

Navitrack System OS Knee Universal 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Orthosoft, Inc. dba Zimmer CAS 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
    75614
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1881-2017
  • 사례 시작날짜
    2011-10-06
  • 사례 출판 날짜
    2017-04-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154874
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • 원인
    Zimmer cas voluntarily conducted a retrospective recall of the navitrack system - os knee universal software orthosoft-unitkr-2.3.2.6, due to a calibration sequence crash.
  • 조치
    Zimmer sent a Medical Device Field Notification letter dated December 6, 2011, to all affected customers. This is a retrospective report of a correction taken on 6 December 2011. The software issues were fixed in the new software version 2.3.3.0. Recall notices were distributed on December 6, 2011. Telephone: 18663367846 (US & Canada) or 5143958883 (International), Email: cassupport@zimmercas.com Customers with questions should call 1-866-336-7846 (US & Canada) 514-395-8883 (International). For questions regarding this recall call 574-372-4487.

Device

Navitrack System OS Knee Universal
  • 모델명 / 제조번호(시리얼번호)
    Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
  • 제품 설명
    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument || CAS Software application intended to assist in the placement of total knee replacement components
  • Manufacturer
    Orthosoft, Inc. dba Zimmer CAS

Manufacturer

Orthosoft, Inc. dba Zimmer CAS
  • 제조사 주소
    Orthosoft, Inc. dba Zimmer CAS, 75 Queen St #3300, Montreal Canada
  • 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