Device Recall TiMagna Fx WasherTiVersaFXII Femoral Fixation System S/C Plates 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
    66196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0129-2014
  • 사례 시작날짜
    2013-08-28
  • 사례 출판 날짜
    2013-11-01
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-04-30
  • 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
    none - Product Code NDG
  • 원인
    Zimmer recently conducted a review of historic packaging validations completed. based on this review, it was determined that a subset of product packaged at a single zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. the number of samples required for packaging testing, to provide statisti.
  • 조치
    The firm, Zimmer Inc., sent a letter entitled "Voluntary Recall of Ti-VFxII Condylar Tube Plates and Ti-Washers" dated September 12, 2013 to its customer. The letter described the product, problem and action to be taken. The customer was instructed to immediately discontinue use of the listed products. A Sales representatives from Zimmer K.K. or agencies will be in contact with you. Zimmer Inc. is planning to resume product manufacturing upon the completion of package validation review. Zimmer K.K. will contact you when a detailed schedule has been determined. If you have any questions, contact Zimmer K.K. Safety Office (9:00 to 17:00; closed weekends and public holidays) TEL: 0120-015-180.

Device

  • 모델명 / 제조번호(시리얼번호)
    00365888 00366414 60004449 60146383 60186345 60197210 60208698 60282431 60389889 60405108 60407931 60869220 61080693 61327948 61375455 61754656 61923922 60004450 60208699 60276711 60282432 60869221 61080694 61391007 60024174 61080695 61328382 61375457 61421602 24416600 60084846 60154683 60186372 60197211 60199098 60266079 60266080 60279692 60373565 60405109 60407932 60415506 60428806 60586953 60725599 61041311 61261269 61287734 61309831 61391008 61698392 61732770 61933545 60024175 60146386 60186373 60197212 60208702 61041313 61375459 61505519 61895287 62020570 60390423 60407933 60855531 60855535 60855536 60855537 61261270 23318000 23349600 60065066 60088732 60118716 60126399 60137449 60150012 60160727 60252568 60282398 60321685 60341615 60373346 60407903 60415261 60463630 60582482 60629012 60665668 60665669 60676030 60830532 60926411 60982760 61041155 61041156 61052948 61079688 61088994 61228687 61426136 61559639 61599273 61683731 61732260 61765106 61804102 61829985 61853628 61885960 61926992 61992671 62058073 62152073 62157809
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    International distribution: Japan only.
  • 제품 설명
    Ti-Magna Fx Washer || Ti-Versa-FX¿II Femoral Fixation System S/C Plates || The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.
  • 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