Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface, 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
    53399
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0216-2010
  • 사례 시작날짜
    2009-10-08
  • 사례 출판 날짜
    2009-11-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-05-16
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code JWH
  • 원인
    The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
  • 조치
    An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lots 60958277, 60964462, 60971779, 60971785, 60987837, 60992942, 60992943, 61001552, 61012258, 61017697, 61023614, 61036345, 61045081, 61058616, 61058617, 61075241, 61078754, 61085873, 61091196, 61106558, 61114166 and 61117051.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • 제품 설명
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-020-13. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer

Manufacturer

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