Events

Device Recall Zimmer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Zimmer Manufacturing B.V. 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
    72900
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1163-2016
  • 사례 시작날짜
    2016-01-11
  • 사례 출판 날짜
    2016-03-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143892
  • 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
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • 조치
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61672127 61762385 61804344 61866511 61896678 61940978 61952481 62271940 61906562 61909135 61909415 61708338 61758144 61861311 61879904 61952217 61953206 62130792 62230218 61957579 61762384 61884793 61955865 61866504 61758145 61804342 61866505 61866507 61896676 61896677 61940979 61952464 61952470 61953207 61955866 61957580 62124267 62124268 62124270 62124271 62130789 62130790 62241717 62310746 62310749 61758148 61861312 61952480 62230213 370683 61849236 61866510 61955864 62130791 62271939 370686 61758149 61925936 61640891 61714083 61804347 61884794 62127926 62230216 62271941 371037 61915562 370921 371035 37107414 61901766 62230196 61920050 61708350 370684 371070 61866503 61901767 61920919 62271937 371073 370622 62105420 370541 61828070 61808819 61843710 62016616 62103684 62136373 62141977 61835223 62136374 61839354 61672109 61753030 61753032 61753034 61824698 61844439 61867392 61888711 61936534 61964334 61977116 62005744 62024991 62050761 62050762 62073658 62073659 62076982 62136372 62152758 62152760 62170197 62262094 62279833 62279837 61758137 61822588 61835476 61918578 61948382 62050763 62141993 370396 61918579 62076939 61795499 61815573 62076932 370692 370693 370730 370964 61830495 370685 61677255 61748730 61808359 61822583 61842559 61867373 61908955 61934167 61963949 61980443 61980446 62042558 62063861 62076925 62080167 61677273 61782895 61782896 61867374 61884795 61948380 61977103 61983645 61983646 62089477 62146230 62152751 62291273 61677282 61782897 61808360 61808361 61843709 61867375 61952218 61952219 61952220 61964340 62036972 62042757 62045189 62076927 62080170 62080181 62146235 62155394 62229855 62291274 370403 61681367 61681373 61867376 61983644 62046417 62060741 370404 370646 61997574 62046418 61825005 61753013 61977113 61819370 61819371 61824612 61843711 61867377 61948381 61980449 62011138 62011140 62038162 62045194 62086496 62089480 62103701 62135603 62152755 62183003 62183004 62279817 62330820 61677290 61716223 61753015 61753022 61753024 61753025 61808426 61808427 61808428 61824613 61824614 61824616 61835471 61844406 61867378 61867379 61867380 61867381 61915560 61951253 61951254 61951255 61964342 61964343 61987620 61987621 62014376 62014377 62014378 62018801 62018802 62018803 62027398 62027399 62042370 62053145 62053148 62053154 62053156 62053710 62089481 62089482 62089483 62099558 62099561 62103702 62103704 62116683 62116684 62116687 62116688 62120594 62120596 62170202 62170205 62170206 62204718 62204719 62204721 62204723 62204725 62262089 62262090 62262091 62262093 62272830 62272832 62272833 62298846 62298847 62298848 62298849 61659699 61659726 61659774 61677298 61677304 61681413 61681416 61681417 61681418 61681421 61758104 61758109 61758117 61758118 61758121 61758122 61758124 61758128 61782903 61782904 61782905 61808431 61808433 61808434 61808436 61808437 61808438 61808439 61808440 61808442 61808443 61808444 61819608 61824626 61824629 61824630 61824632 61824634 61835472 61835473 61835474 61835475 61844435 61844438 61867382 61867383 61867384 61867385 61867387 61884796 61886392 61888709 61888710 61908956 61908957 61918355 61918356 61923865 61923866 61929828 61929829 61929830 61929831 61966597 61966598 61966599 61980451 62014379 62014380 62018812 62018814 62018816 62027400 62027401 62037014 62038664 62038665 62038667 62038668 62038669 62045209 62049334 62049338 62080197 62080207 62080210 62086486 62086487 62086488 62086490 62086493 62093233 62093234 62093235 62095809 62095810 62095811 62099565 62099568 62099572 62120597 62120598 62120599 62120601 62135604 62135605 62135606 62135610 62146241 62146242 62146243 62155395 62155397 62155398 62161720 62161724 62161727 62172974 62173029 62173030 62173031 62173032 62173035 62173042 62173043 62173044 62173045 62173046 62229857 62229858 62229860 62246482 62246483 62246484 62246485 62279825 62279828 62315755 62315757 62320746 62333361 62333362 62333363 62333366 62333369 62337749 62337753 62339578 62339579 62339580 62342069 62342070 37107668 37107669 37107670 37107671 37107672 61782906 61782908 61808429 61824697 61867388 61867389 62016620 62016623 62041767 62073625 62073628 62073632 62095994 62099575 62103699 62141986 62141987 62141988 62183058 62183059 62183060 62183061 62183062 62183063 62183066 62183067 62320754 62320755 62320756 37107673 37107674 37107675 37107676 37107677 37107678 61753038 61753039 61867390 61884797 62016635 62076926 62099578 62103696 62135614 62135615 62161657 62161691 62193544 62193545 62193547 62193556 62193565 62193576 62320759 61917706 61917707 61918353 62199493 62199499 62199501 61917706R 62199493N 61920222 62229852 370402 61842560 61867391 61977132 61822589 62054561 62144013 62262095 61824699 62026914 62037901 62103687 62241825 61693785 61693790 61842561 61855925 61997573 62036974 62063865 62152763 62241827 370398 370993 62029920 62073636 62046427 62063869 370966 61915559 61934170 62105405 61934170R 370400 37107622 37107667 370965 61844440 62116679 370644 370962 61979181 61987631 62076943 370963 61822591 61892623 370514 370694 61753036 370529 370991 370530 370992 370695 61867417 61776782 61839352 62063874 62279803 61839346 61923864 61839351 61677237 61806979 61980442 62027396 62054541 62116677 62291211 62291211N 61782893 61842563 62039916 62228183 61934155 61950095 61950096 62014213 61888708 62279805 62279805N 61989416 61895939
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 65 consists of all product under product code: KTT and same usage: || Item no: || 119413594 VERSA-FX II KEYLESS SHORT || 119413595 VERSA-FX II KEYLESS SHORT || 119413596 VERSA-FX II KEYLESS SHORT || 119413004 VERSA-FX II KEYLESS TUBE || 119413005 VERSA-FX II KEYLESS TUBE || 119413006 VERSA-FX II KEYLESS TUBE || 119413008 VERSA-FX II KEYLESS TUBE || 119413504 VERSA-FX II KEYLESS TUBE || 119413505 VERSA-FX II KEYLESS TUBE || 119413506 VERSA-FX II KEYLESS TUBE || 119413508 VERSA-FX II KEYLESS TUBE || 119414004 VERSA-FX II KEYLESS TUBE || 119414005 VERSA-FX II KEYLESS TUBE || 119414006 VERSA-FX II KEYLESS TUBE || 119414008 VERSA-FX II KEYLESS TUBE || 119414504 VERSA-FX II KEYLESS TUBE || 119414506 VERSA-FX II KEYLESS TUBE || 119414508 VERSA-FX II KEYLESS TUBE || 119415004 VERSA-FX II KEYLESS TUBE || 119415005 VERSA-FX II KEYLESS TUBE || 119415006 VERSA-FX II KEYLESS TUBE || 119415008 VERSA-FX II KEYLESS TUBE || 119313094 VERSA-FX II SHORT TUBE PL || 119313095 VERSA-FX II SHORT TUBE PL || 119313096 VERSA-FX II SHORT TUBE PL || 119313594 VERSA-FX II SHORT TUBE PL || 119313595 VERSA-FX II SHORT TUBE PL || 119313596 VERSA-FX II SHORT TUBE PL || 119314094 VERSA-FX II SHORT TUBE PL || 119314594 VERSA-FX II SHORT TUBE PL || 119314595 VERSA-FX II SHORT TUBE PL || 119315094 VERSA-FX II SHORT TUBE PL || 119315095 VERSA-FX II SHORT TUBE PL || 119313002 VERSA-FX II STD TUBE PLAT || 119313003 VERSA-FX II STD TUBE PLAT || 119313004 VERSA-FX II STD TUBE PLAT || 119313005 VERSA-FX II STD TUBE PLAT || 119313006 VERSA-FX II STD TUBE PLAT || 119313008 VERSA-FX II STD TUBE PLAT || 119313010 VERSA-FX II STD TUBE PLAT || 119313012 VERSA-FX II STD TUBE PLAT || 119313502 VERSA-FX II STD TUBE PLAT || 119313503 VERSA-FX II STD TUBE PLAT || 119313504 VERSA-FX II STD TUBE PLAT || 119313505 VERSA-FX II STD TUBE PLAT || 119313506 VERSA-FX II STD TUBE PLAT || 119313508 VERSA-FX II STD TUBE PLAT || 119313510 VERSA-FX II STD TUBE PLAT || 119313512 VERSA-FX II STD TUBE PLAT || 119314002 VERSA-FX II STD TUBE PLAT || 119314003 VERSA-FX II STD TUBE PLAT || 119314004 VERSA-FX II STD TUBE PLAT || 119314005 VERSA-FX II STD TUBE PLAT || 119314006 VERSA-FX II STD TUBE PLAT || 119314502 VERSA-FX II STD TUBE PLAT || 119314503 VERSA-FX II STD TUBE PLAT || 119314504 VERSA-FX II STD TUBE PLAT || 119314505 VERSA-FX II STD TUBE PLAT || 119314506 VERSA-FX II STD TUBE PLAT || 119314510 VERSA-FX II STD TUBE PLAT || 119314512 VERSA-FX II STD TUBE PLAT || 119315003 VERSA-FX II STD TUBE PLAT || 119315004 VERSA-FX II STD TUBE PLAT || 119315005 VERSA-FX II STD TUBE PLAT || 119315006 VERSA-FX II STD TUBE PLAT || 119315012 VERSA-FX II STD TUBE PLAT || 119315014 VERSA-FX II STD TUBE PLAT || 119315018 VERSA-FX II STD TUBE PLAT || 119309008 VERSA-FX II SUPRACONDYLR || 119309010 VERSA-FX II SUPRACONDYLR || 119309012 VERSA-FX II SUPRACONDYLR || 119309014 VERSA-FX II SUPRACONDYLR || 119309506 VERSA-FX II SUPRACONDYLR || 119309508 VERSA-FX II SUPRACONDYLR || 119309510 VERSA-FX II SUPRACONDYLR || 119309512 VERSA-FX II SUPRACONDYLR || 119309514 VERSA-FX II SUPRACONDYLR || 119309516 VERSA-FX II SUPRACONDYLR || 119309522 VERSA-FX II SUPRACONDYLR || Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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