Device Recall PERSONA (TM) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer, 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
    68653
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2289-2014
  • 사례 시작날짜
    2014-07-01
  • 사례 출판 날짜
    2014-08-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-06-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Tray, surgical, instrument - Product Code FSM
  • 원인
    The firm discovered that the current personal tibial/general fixed bracket trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. the drill bracket and drill guide are not the correct geometry to allow for a proper fit in the persona fixed case kit which could lead to improper sterilization of the tibial drill and stop guide.
  • 조치
    On July 1, 2014, Zimmer, Inc. issued recall notification to their consignees via e-mail and/or letter. Notification included affected product issue and instructions for returning the affected product. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with affected inventory were also notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory. Distributors are responsible for returning on-hand affected products to Zimmer and ensuring all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.

Device

  • 모델명 / 제조번호(시리얼번호)
    Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.
  • 제품 설명
    PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile || The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
  • 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