Devices

Device Recall Zimmer

  • Modèle / numéro de série
    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
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    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.
  • 1 Event

Fabricant

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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

263 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

Device Recall Zimmer Periarticular Locking Plate System, Distal Medial Humeral Locking Plate, Short
  • Modèle / numéro de série
    Item No. 47-2358-107-11; Lots 61803307, 61969598, and 62084127 Item No. 47-2358-107-15; Lot 61825319
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Internationally Distributed in China only.
  • Description du dispositif
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM || DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT || RIGHT 11 HOLES 178 MM LENGTH || STERILE RX ONLY || Product Usage: Usage: || The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Unicompartmental Knee Femoral Component
  • Modèle / numéro de série
    Part Number Range:00-5842-011/017-01/02
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
  • Description du dispositif
    Zimmer¿ Unicompartmental Knee Femoral Component. || Indicated for patients with painful and/or disabling knee joint.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Periarticular Plating System
  • Modèle / numéro de série
    Item #'s:  00-2347-001-12 00-2347-001-14 00-2347-001-16 00-2347-001-18 Lot #s: All lots with an expiration date prior to July 24, 2023
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    FEM COND BUTTRESS PLT, RT.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modèle / numéro de série
    Item Numbers:  47-2357-101-14 47-2357-101-18 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    DIST LAT FEM LOCK PLT, RT
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modèle / numéro de série
    Part Number Lot Number 00450001100 62072174 00450001100 62248802 00450001100 62264833 00450001100 62267033 00450001100 62279041 00450001100 62279043 00450001100 62331803 00450001100 62331808 00450001100 62337755 00450001100 62343558 00450001100 62357496 00450001100 62357497 00450001100 62397412 00450001100 62397413 00450001100 62430803 00450001200 11007903 00450001200 11008443 00450001200 62168362 00450001200 62239775 00450001200 62239789 00450001200 62267626 00450001200 62267627 00450001200 62279044 00450001200 62279050 00450001600 62168363 00450001600 62239794 00450001600 62264836 00450001600 62264837 00450001600 62267631 00450001600 62290823 00450001600 62290824 00450001600 62297847 00450001600 62297848 00450001600 62310752 00450001600 62316170 00450001600 62323809 00450001600 62331810 00450001600 62337757 00450001600 62349862 00450001600 62357499 00450001600 62372416 00450001600 62405309 00450001600 62419534 00450001200 62285546 00450001200 62290833 00450001200 62290835 00450001200 62372414 00450001200 62375863 00450001200 62397414 00450001200 62405304 00450001200 62416035 00450001200 62419530 00450001200 62430804 00450001300 62160227 00450001300 62163379 00450001300 62215393 00450001300 62264834 00450001300 62267628 00450001300 62267629 00450001300 62279045 00450001300 62279051 00450001300 62285548 00450001300 62290836 00450001300 62299551 00450001300 62331811 00450001300 62337756 00450001300 62349856 00450001300 62349857 00450001300 62368383 00450001300 62375865 00450001300 62375868 00450001300 62378060 00450001300 62397415 00450001300 62397416 00450001300 62409032 00450001300 62409033 00450001300 62416036 00450001300 62419532 00450001300 62430805 00450001400 11007904 00450001400 11008529 00450001400 62163382 00450001400 62208153 00450001400 62239776 00450001400 62239786 00450001400 62264835 00450001400 62279052 00450001400 62290829 00450001400 62299552 00450001400 62305739 00450001400 62310750 00450001400 62316168 00450001400 62316169 00450001400 62343549 00450001400 62343550 00450001400 62343551 00450001400 62349858 00450001400 62368384 00450001400 62372415 00450001400 62378062 00450001400 62393803 00450001400 62393804 00450001400 62397417 00450001400 62405306 00450001400 62409034 00450001400 62416038 00450001400 62416039 00450001400 62416040 00450001400 62419533 00450001400 62459855 00450001500 62072172 00450001500 62208154 00450001500 62215392 00450001500 62220672 00450001500 62220674 00450001500 62226570 00450001500 62279046 00450001500 62279053 00450001500 62285550 00450001500 62290842 00450001500 62331809 00450001500 62349859 00450001500 62349861 00450001500 62357498 00450001500 62358906 00450001500 62378063 00450001500 62393805 00450001500 62397418 00450001500 62405308 00450001500 62416042 00450001500 62439673 00450001600 11007906 Part Number Lot Number 00830001100 62264850 00830001100 62316172 00830001100 62323776 00830001100 62337212 00830001100 62357509 00830001200 62204729 00830001200 62215395 00830001200 62316173 00830001200 62323778 00830001200 62331816 00830001200 62343559 00830001300 11008422 00830001300 62204730 00830001300 62220676 00830001300 62267038 00830001300 62267040 00830001300 62323781 00830001300 62331817 00830001300 62337216 00830001300 62349869 00830001300 62409040 00830001400 62208150 00830001400 62264851 00830001400 62310756 00830001400 62316177 00830001400 62323783 00830001400 62343560 00830001400 62343561 00830001400 62368388 00830001500 62204731 00830001500 62215396 00830001500 62305743 00830001500 62323784 00830001500 62343563 00830001500 62357510 00830001500 62428994 00830001600 62264852 00830001600 62299553 00830001600 62316174 00830001600 62323786 00830001600 62337210 00830001600 62343565 00830001600 62357511
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Description du dispositif
    Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 || Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: " Rheumatoid arthritis. " Post-traumatic arthritis. " Degenerative arthritis. This device is intended for cemented use only.
  • Manufacturer
    Zimmer, Inc.
258 en plus