Events

Device Recall NexGen LPS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ZIMMER ORTHOPEDIC MFG LTD 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
    78960
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0663-2018
  • 사례 시작날짜
    2017-07-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160970
  • 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, metal/polymer, mobile bearing - Product Code NJL
  • 원인
    There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
  • 조치
    On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131

Device

Device Recall NexGen LPS
  • 모델명 / 제조번호(시리얼번호)
    Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
  • 제품 설명
    NexGen LPS Femoral Component, Left and Right, Size G || Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
  • Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD

Manufacturer

ZIMMER ORTHOPEDIC MFG LTD
  • 제조사 주소
    ZIMMER ORTHOPEDIC MFG LTD, Building No 2 East Park, Shannon Industrial Estate, Shannon Ireland
  • 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