NexGen Complete Knee Solution Stemmed tibial broach impactor 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
    55363
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0609-2011
  • 사례 시작날짜
    2010-04-16
  • 사례 출판 날짜
    2010-12-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-09-12
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • 원인
    The impactor may disassemble or detach during use. the detached piece may not be observed intraoperatively and may be left in the surgical site. complications may include pain, infection, and prolongation in surgery. these complications may also require revision surgery.
  • 조치
    Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.

Device

  • 모델명 / 제조번호(시리얼번호)
    61650800, 64173900, 64314000, 64592700, 64899900, 65307200, 66384700, 67271500, 68001000, 68507500, 70066700, 72635200, 73040600, 74330100, 78288600, 78775900, 79027000, 79301900, 79414800, 79911900, 50006600, 50243100, 50435900, 51091100, 05478400, 52676400, 53616000, 53780600, 54122000, 54289900, 54601600, 55023000, 55023000, 55307800, 56221200, 56599400, 56760200, 56795200, 56934500, 56974400, 57038500, 57111600, 57128100, 57241400, 57440800, 57329200, 57510900, 57543000, 57575000, 57645600, 57854100, 57918600, 57808100, 58005700, 58318100, 58318200, 58575700, 58812400, 58784400, 59456600, 59183600, 59671000, 59660300, 59786900, 60481100, 60844300, 60903700, 60939100, 61813100, 62260000, 05631100, 62994200, 64835300, 65403600, 65861500, 66614100, 66883200, 67441900, 67599300, 68466000, 68764200, 69175100, 69286900, 70153900, 70294600, 70658600, 71027500, 71280200, 71572500, 71866600, 72502300, 72829600, 73433500, 74078000, 74644700, 74750900, 75331100, 75504400, 76422600, 79626500, 41996400, 52288600, 53220100, 54000500, 60007281, 60025415, 60029968, 60034339, 60056415, 60066606, 60064664, 60077494, 60079251, 60091628, 60092158, 60102687, 60105706, 60115562, 60117109, 60120485,  60124571, 60137142, 60149310, 60160018, 60174138, 60194573, 60195084, 60209845, 60219302, 60224592, 60226046, 60225877, 60240482, 60271491, 60278677, 60280712, 60302621, 60314459, 60328822, 60341569, 60359101, 60362634, 60366062, 60378347,  60380488, 60398085, 60401003, 60425875, 60439542, 60451190, 60523326, 60547208, 60565239, 60568430, 60582612, 60587278, 60603208, 60652168, 60685947, 60723702, and 60781789.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
  • 제품 설명
    NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
  • Manufacturer

Manufacturer

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