Device Recall Persona Cemented Tibial Broach Inserter/Extractor 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
    69906
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0853-2015
  • 사례 시작날짜
    2014-12-04
  • 사례 출판 날짜
    2014-12-23
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-05-13
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • 원인
    The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. zimmer received one complaint indicating the magnet cover of a persona cemented tibial broach inserter/extractor handle lot 62085420 was missing after broaching the tibia. postoperative radiographs were inspected and the magnet cover was not identified. the investigation indi.
  • 조치
    Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755

Device

  • 모델명 / 제조번호(시리얼번호)
    Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
  • 제품 설명
    Persona Cemented Tibial Broach Inserter/Extractor. || The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
  • 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