Events

Device Recall Free Lock Femoral Fixation System 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
    65513
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2094-2013
  • 사례 시작날짜
    2013-06-19
  • 사례 출판 날짜
    2013-08-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120085
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • 원인
    Single packaging configuration used for the versa-fx-ii femoral fixation system failed the leak test compromising the sterility of the product.
  • 조치
    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 11, 2013 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect the device according to the insert instructions; not use the device if damage to the corner of the inner tray is observed, and contact the firm for return and questions. Customers should also keep this notification in mind and inform Zimmer of product with this condition using zimmer.per@zimmer.com. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.

Device

Device Recall Free Lock Femoral Fixation System
  • 모델명 / 제조번호(시리얼번호)
    60619089 60619099 60611043 60619098 60611039 60632532 60668205 60668241 60669598 60668240 60668247 60685095 60685102 60679344 60685066 60685104 60685096 60674425 60704366 60704367 60704370 60714913 60704368 60714914 60714915 60714916 60726325 60744850 60714917 60726326 60754395 60763214 60763215 60763216 60787010 60787191 60787194 60787198 60787190 60787192 60787193 60787196 60787199 60787197 60787189 60803585 60807846 60807848 60803584 60787195 60815493 60845778 60845777 60844062 60868471 60877490 60877489 60885169 60885171 60911343 60932392 60932393 60938417 60938419 60943339 60938421 60944523 60787188 60972802 60972803 60998290 61005007 60972801 61020337 61020339 61020335 61037487 61037488 61037489 61041090 61037490 61027502 61027507 61027516 61041091 61027510 61027523 61027511 60868468 61076083 61086851 61041093 61092223 61092239 61092241 61103196 61103197 61103198 61103201 61101549 61103199 61101547 61041089 61140177 61162619 61162620 61169415 61169416 61169417 61179752 61169418 61198454 61223003 61162621 61092237 61228339 61264745 61264742 61264746 61294830 61286877 61304472 61286880 61309349 61309350 61286879 61341982 61341983 61357166 61357172 61357171 61359993 61286878 61446407 61456386 61375171 61458224 61459335 61474332 61464382 61476801 61476802 61476803 61427113 61427114 61475572 61427115 61474333 61474334 61482163 61482164 61453113 61493898 61511595 61516366 61516367 61523581 61542781 61538715 61542606 61551564 61565482 61565483 61584968 61578708 61596986 61613171 61590988 61596985 61619259 61631410 61631417 61631426 61619260 61640888 61635177 61640895 61640889 61640890 61672132 61672134 61640891 61672127 61708338 61708350 61714083 61729213 61748334 61749017 61749009 61749012 61749027 61758148 61804344 61861311 62105419 62271938 62271936 62271934 62310747
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
  • 제품 설명
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

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