Events

Device Recall Endo & Unipolar Femoral Heads 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
    68818
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2547-2014
  • 사례 시작날짜
    2014-07-22
  • 사례 출판 날짜
    2014-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129069
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • 원인
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • 조치
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Endo & Unipolar Femoral Heads
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers  00781804100, 00781804200, 00781804300, 00781804400, 00781804500, 00781804600, 00781804700, 00781804800, 00781804900, 00781805000, 00781805100, 00781805200, 00781805300, 00781805400, 00781805500, 00781805700, 00781806000, 00781806300, 00902604101, 00902604201, 00902604301, 00902604401, 00902604501, 00902604601, 00902604701, 00902604801, 00902604901, 00902605001, 00902605101, 00902605201, 00902605301, 00902605401, 00902605501, 00902605701, 00902606001, 00902606301, 451000041, 451000042, 451000043, 451000044, 451000045, 451000046, 451000047, 451000048, 451000049, 451000050, 451000051, 451000052, 451000053, 451000054, 451000055, 451000056, 451000057, 451000058, 451000059, 451000060 EXPIRATION DATE PRIOR TO 2024-01
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Endo & Unipolar Femoral Heads: || ENDO FEMORAL HEAD 41MM DIA || ENDO FEMORAL HEAD 42MM DIA || ENDO FEMORAL HEAD 43MM DIA || ENDO FEMORAL HEAD 44MM DIA || ENDO FEMORAL HEAD 45MM DIA || ENDO FEMORAL HEAD 46MM DIA || ENDO FEMORAL HEAD 47MM DIA || ENDO FEMORAL HEAD 48MM DIA || ENDO FEMORAL HEAD 49MM DIA || ENDO FEMORAL HEAD 50MM DIA || ENDO FEMORAL HEAD 51MM DIA || ENDO FEMORAL HEAD 52MM DIA || ENDO FEMORAL HEAD 53MM DIA || ENDO FEMORAL HEAD 54MM DIA || ENDO FEMORAL HEAD 55MM DIA || ENDO FEMORAL HEAD 57MM DIA || ENDO FEMORAL HEAD 60MM DIA || ENDO FEMORAL HEAD 63MM DIA || ENDO FEM HEAD 41MM || ENDO FEM HEAD 42MM || ENDO FEM HEAD 43MM || ENDO PROS HEAD 44MM || ENDO FEM HEAD 45MM || ENDO FEM HEAD 46MM || ENDO FEM HEAD 47MM || ENDO FEM HEAD 48MM || ENDO FEM HEAD 49MM || ENDO FEM HEAD 50MM || ENDO FEM HEAD 51MM || ENDO FEM HEAD 52MM || ENDO FEM HEAD 53MM || ENDO FEM HEAD 54MM || ENDO FEM HEAD 55MM || ENDO FEM HEAD 57MM || ENDO FEM HEAD 60MM || ENDO FEM HEAD 63MM || UNIPOLAR COMPONENT, 41MM || UNIPOLAR COMPONENT, 42MM || UNIPOLAR COMPONENT, 43MM || UNIPOLAR COMPONENT, 44MM || UNIPOLAR COMPONENT, 45MM || UNIPOLAR COMPONENT, 46MM || UNIPOLAR COMPONENT, 47MM || UNIPOLAR COMPONENT, 48MM || UNIPOLAR COMPONENT, 49MM || UNIPOLAR COMPONENT, 50MM || UNIPOLAR COMPONENT, 51MM || UNIPOLAR COMPONENT, 52MM || UNIPOLAR COMPONENT, 53MM || UNIPOLAR COMPONENT, 54MM || UNIPOLAR COMPONENT, 55MM || UNIPOLAR COMPONENT, 56MM || UNIPOLAR COMPONENT, 57MM || UNIPOLAR COMPONENT, 58MM || UNIPOLAR COMPONENT, 59MM || UNIPOLAR COMPONENT, 60MM
  • Manufacturer
    Zimmer, Inc.

Manufacturer

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