Events

Device Recall Orthosize 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
    76442
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1495-2017
  • 사례 시작날짜
    2017-02-14
  • 사례 출판 날짜
    2017-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153219
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    Digital templates were created with the incorrect files.
  • 조치
    On 2/14/2017 URGENT MEDICAL DEVICE CORRECTION notifications were sent to the affected users and 3rd party users via email. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for 3rd party users to respond to the formal recall notification. Orthosize Templating Users In approximately 6 weeks you will receive a notice that an update is available for the Orthosize Templating App. Upon selecting the app you will be required to update the app in order to use it. 1. Review this notification and ensure affected personnel are aware its contents. 2. Immediately update the app when the update becomes available. 3. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com Digital Template Users (3rd party) 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately update your systems to include the revised digital templates included with notice. 3. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your records. 4. If after reviewing this notice you have further questions or concerns please call 411 Technical Services at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com

Device

Device Recall Orthosize
  • 모델명 / 제조번호(시리얼번호)
    Orthosize Templating Version 1.2.6
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • 제품 설명
    Orthosize Templating Version 1.2.6 || Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
  • 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