Events

Phoenix Antegrade Femoral Nail Instrument 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Biomet, 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
    79146
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0774-2018
  • 사례 시작날짜
    2017-09-13
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161442
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    Fracture of the bolt connecting the insertion guide to the intramedullary nail during insertion of the femoral nail.
  • 조치
    On September 13, 2017 an URGENT MEDICAL DEVICE RECALL REMOVAL was issued to customers requesting that they review inventory and quarantine affected product, which will be immediately returned to recalling firm. Also to notify any customers who may have received product. Questions or concerns can be directed to Customer Service at 574-371-3071

Device

Phoenix Antegrade Femoral Nail Instrument
  • 모델명 / 제조번호(시리얼번호)
    Finished Lot order: M370490 M354450 M321540 M975460 M639280 M426760 M629950 M629930 M073530 M073540 M073550 M073560 M073570 M073580 M073590 M073600 M073610 M627490 M656470 M656580 M656590 M656600 M656610 M656620 M656640 M656660 M966880 M967050 M967060 M967070 M980260 M980270 M508490 M508410 M508500 M508450 M508480 M508520 M508470 M508510 M508460
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution includes US Nationwide.
  • 제품 설명
    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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