Device Recall Versys BuildUp Block 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
    66968
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0610-2014
  • 사례 시작날짜
    2013-12-10
  • 사례 출판 날짜
    2013-12-30
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-09-11
  • 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, shoulder, non-constrained, metal/polymer cemented - Product Code JDI
  • 원인
    Zimmer is initiating a lot specific recall of the cpt hip stem, versys build-up block, and trabecular metal reverse glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. product labels and patient labels are correct.
  • 조치
    Zimmer sent an Urgent Medical Device Recall letter dated December 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. If affected product was found, it should be quarantines and their Zimmer representative notified. The Zimmer sales representative will remove the recalled product from their facility. Customers with questions were instructed to call 1-877-946-2761. .

Device

  • 모델명 / 제조번호(시리얼번호)
    Part 00-7871-001-10 Lot 62359872
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.
  • 제품 설명
    Versys Build-Up Block || The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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