Events

Device Recall Vitality Spinal Fixation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet Spine 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
    77251
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2318-2017
  • 사례 시작날짜
    2017-05-10
  • 사례 출판 날짜
    2017-05-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155554
  • 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
    Accessories, fixation, spinal intervertebral body - Product Code LYQ
  • 원인
    Zimmer biomet is conducting a medical device recall for vitality t27 final drivers and vitality torque limiting handle  90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.
  • 조치
    Consignees will be notified on 5/15/17 via certified mail to return products.

Device

Device Recall Vitality Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
  • 제품 설명
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
  • Manufacturer
    Zimmer Biomet Spine Inc.

Manufacturer

Zimmer Biomet Spine Inc.
  • 제조사 주소
    Zimmer Biomet Spine Inc., 10225 Westmoor Dr, Westminster CO 80021-2702
  • 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