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-2090-2013
  • 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=119461
  • 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)
    60621340 60621339 60621342 60621345 60639475 60621341 60621338 60621344 60671954 60653031 60653066 60671958 60639474 60653032 60653043 60653053 60653063 60671956 60671957 60705048 60653057 60653069 60671955 60621343 60705047 60714810 60705044 60701995 60705045 60701998 60702002 60705043 60702006 60680439 60736748 60781210 60781213 60781212 60781211 60782044 60782047 60782049 60705046 60714808 60782048 60782043 60782050 60736749 60714809 60736750 60782046 60736752 60736753 60736756 60782040 60782045 60736754 60781209 60782041 60812142 60812145 60782037 60812143 60812147 60815943 60564710 60812146 60817011 60782042 60812141 60812144 60812148 60815946 60830649 60830650 60830670 60830652 60572991 60736755 60736758 60862361 60862362 60862363 60862364 60862365 60862366 60862367 60879681 60862369 60879678 60862368 60564708 60915347 60931209 60931208 60931211 60931212 60931213 60931215 60973693 60973694 61026401 61026409 61026399 61026402 61026406 61026414 61026415 61026405 61026403 61026407 61026404 61045321 61026411 61037587 61037589 61037588 61037586 61037590 61037591 61063230 61069128 61063232 61069129 61069131 61069132 61077253 61083091 61083092 61083093 61077251 61108038 61110037 61110038 61114907 60879682 61120993 61120992 61141516 61141512 61141515 61141517 61142760 61141513 61141514 61142759 61142761 61142762 61171562 61171564 61171565 61184407 61184409 61184410 61141518 61142763 61179647 61184408 61195103 61184405 61184406 61195101 61195104 61195097 61195095 61195096 61195102 61195094 61195099 61195098 61209057 61275454 61251129 61251131 61209056 61209053 61275452 61278174 61278175 61278176 61284325 61284326 61284327 61284328 61286932 61274845 61209054 61209055 61251130 61278171 61284322 61284324 61286935 61286938 61286940 61195093 61278172 61278173 61275456 61268917 61278177 61399023 61310083 61345993 61393376 61400219 61345995 61379219 61405653 61420626 61420628 61420629 61420631 61405652 61466805 61466807 61466808 61466814 61428488 61466840 61428485 61502706 61466842 61491356 61502705 61534196 61491355 61609889 61625237 61614765 61609887 61616173 61609888 61589581 61663369 61663371 61663372 61663373 61663375 61629793 61644214 61663376 61762401 61769259 61700052 61762403 61762486 61762492 61784953 61798403 61828057 61849821 61906712 62046409 62106371 62120939 62120941 62124273 62197640 62197642
  • 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
    Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. || ZIMMER Compression Hip Screw, 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