Devices

Zimmer

  • Modelo / Serial
    POROUS PATELLA 32MM X 10MM 61728647 61762587 62028703 62082384 61998061 61728648 61781040 62028701 62082387 61998065 61762578 61781037 62028702 62100771 62003279 61762581 61781039 62028705 62100774 62003280 61762584 61796452 62051894 62100773 61998062 61762585 61796458 62051896 62100775 61998064 61770640 61770641 62051895 62100777 62003281 61770642 61796459 62109088 62109087 62003282 61762579 61781036 62109089 62100768 62003283 61762580 61770638 62100770 62100769 62007635 61762582 61781038 62109090 62100772 62007636 61762583 61796451 62119906 62100776 61874756 61770639 61796460 62119907 62109086 61874758 61890052 61910583 61890055 61914846 61878840 61890053 61910584 61890054 61914845 61878841 61890056 61896662 61910581 61830190 61878844 61844395 61890050 61910582 61830189 61890058 61914849 61830191 61844393 62007641 62082386 61914848 61850552 61850551 62022120 62082388 61946320 61874757 61850549 62022121 62082383 61952743 61878842 61850553 62022123 62082379 61977124 61878843 61890057 62028698 62082381 61977125 61762586 61830192 62119909 62119910 61977130 61796453 61834679 62082385 62119908 61977123 61796455 61834680 62007643 61986196 61977129 61796456 61834681 62009518 61998059 61986193 61796454 61834682 62016304 62051893 61986194 61796457 61834683 62007642 62051890 61896664 61807383 61840029 62016301 62051891 61890051 61814825 61840032 62016303 62051892 61896660 61807384 61840031 62007637 62051897 61896661 61814823 61840030 62007640 62051898 61896663 61814824 61840033 62007644 62051899 61910585 61818410 61844394 62016305 62082380 62016306 61844396 62009517 61914847 62082382  POROUS PATELLA 35MM X 10MM  61722891 61722891 61752727 61752729 61752730 61752728 61762601 61770637 61762596 61762603 61762599 61762602 61776851 61776852 61762597 61762604 61781047 61781046 61796468 61776850 61796465 61796466 61776853 61796467 61796464 61796469 61807385 61818413 61807386 61814827 61818412 61807387 61830194 61830202 61830195 61834685 61834684 61834686 61840037 61840039 61844360 61844362 61844361 61840038 61840036 61844359 61849996 61857275 61857276 61857277 61868653 61878845 61868652 61868654 61874759 61874760 61878846 61868651 61874761 61890059 61896671 61896668 61896672 61896667 61896670 61903294 61903295 61914851 61914850 61914852 61946323 61952744 61977126 61977139 61977140 61986199 61986201 61986202 61986203 62003288 62003289 62003286 62003287 61998082 61998085 61998084 61998083 62003284 62003285 62009514 62016485 62007648 62016483 62016484 62007647 62009515 62016482 62022175 62022176 62028735 62034999 62035003 62035002 62028737 62035001 62042101 62042103 62042104 62028741 62042102 62028740 62051906 62051903 62051904 62051905 62091107 62091109 62091106 62096105 62096108 62100779 62100780 62096107 62100781 62096106 62100778 62119905 62119902 62119903 62119904  POROUS PATELLA 38MM X 10MM   61722890 61722890 61728637 61749117 61749116 61752627 61752628 61752629 61762575 61781045 61776847 61781043 61776846 61776848 61781044 61796472 61796471 61807400 61807401 61814828 61830199 61818425 61834690 61834691 61840041 61840042 61844358 61857297 61868679 61857273 61868680 61868681 61890060 61896673 61903297 61910580 61903296 61914853 61946325 61952745 61977127 61977128 61977133 61986208 61986209 62003292 62003290 62003291 61998096 61998094 62022182 62022183 62028754 62051910 62051909 62051911 62051912 62072548 62072549 62091117 62091119 62091118 62100783 62100782 62100784 62082403 62082404 62082405  POROUS PATELLA 41MM X 10MM   61749111 61749111 61749112 61762576 61776843 61796473 61818426 61830201 61840040 61874763 61874762 61903298 61914854 61946326 61952746 61977134 61977135 61986204 62003294 62003293 62022184 62028758 62051913 62072546 62091121 62100785 62082397
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Foreign.
  • Descripción del producto
    POROUS PATELLA 32MM X 10MM - 00587806532 || POROUS PATELLA 35MM X 10MM- 00587806535 || POROUS PATELLA 38MM X 10MM - 00587806538 || POROUS PATELLA 41MM X 10MM - 00587806541
  • Manufacturer
    Zimmer Trabecular Metal Technology, Inc.
  • 1 Event

Fabricante

Zimmer Trabecular Metal Technology, Inc.
  • Dirección del fabricante
    Zimmer Trabecular Metal Technology, Inc., 10 Pomeroy Rd, Parsippany NJ 07054-3722
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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

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Más información acerca de la data acá

Device Recall Zimmer Periarticular Plating System
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    FEM COND BUTTRESS PLT, RT.
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    DIST LAT FEM LOCK PLT, RT
  • Manufacturer
    Zimmer, Inc.
Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Descripción del producto
    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.
Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modelo / Serial
    Part Number Lot Number 00450002100 62163375 00450002100 62248804 00450002100 62248805 00450002100 62267632 00450002100 62279047 00450002500 62220671 00450002500 62220675 00450002500 62226571 00450002500 62279042 00450002500 62279049 00450002500 62285553 00450002500 62290846 00450002500 62290857 00450002500 62343556 00450002500 62357507 00450002500 62368386 00450002500 62375875 00450002500 62405317 00450002500 62409039 00450002500 62419539 00450002500 62428993 00450002500 62439679 00450002500 62442236 00450002600 11007905 00450002600 62163386 00450002600 62262903 00450002600 62264848 00450002600 62290827 00450002600 62297849 00450002100 62287975 00450002100 62331805 00450002100 62337206 00450002100 62337758 00450002100 62349863 00450002100 62357502 00450002100 62358897 00450002100 62397419 00450002100 62397420 00450002200 62163377 00450002200 62239777 00450002200 62239790 00450002200 62267633 00450002200 62267635 00450002200 62279048 00450002200 62279054 00450002200 62290840 00450002200 62290843 00450002200 62337207 00450002200 62343552 00450002200 62357504 00450002200 62375870 00450002200 62405311 00450002200 62416043 00450002200 62419536 00450002200 62453776 00450002200 62453777 00450002200 62459876 00450002300 11009092 00450002300 62163380 00450002300 62215391 00450002300 62215394 00450002300 62220673 00450002300 62267034 00450002300 62267636 00450002300 62279055 00450002300 62285552 00450002300 62305740 00450002300 62310753 00450002300 62323811 00450002300 62337208 00450002300 62337759 00450002300 62349864 00450002300 62357505 00450002300 62357506 00450002300 62372417 00450002300 62375873 00450002300 62378065 00450002300 62409035 00450002300 62409036 00450002300 62416044 00450002300 62419537 00450002300 62453778 00450002400 62163383 00450002400 62208155 00450002400 62239778 00450002400 62267035 00450002400 62267036 00450002400 62267637 00450002400 62267638 00450002400 62297851 00450002400 62305741 00450002400 62305742 00450002400 62310754 00450002400 62316171 00450002400 62343554 00450002400 62343555 00450002400 62349866 00450002400 62368385 00450002400 62372419 00450002400 62375874 00450002400 62378066 00450002400 62393806 00450002400 62397421 00450002400 62405314 00450002400 62405315 00450002400 62409037 00450002400 62409038 00450002400 62416045 00450002400 62416047 00450002400 62419538 00450002400 62453782 00450002400 62459863 00450002400 62459864 00450002400 62459866 00450002500 11008421 00450002500 11008423 00450002500 62163384 00450002500 62208156 00450002600 62297850 00450002600 62310755 00450002600 62331806 00450002600 62331812 00450002600 62337209 00450002600 62349867 00450002600 62357508 00450002600 62358902 00450002600 62368387 00450002600 62405319 00450002600 62419540 00830002100 62264853 00830002100 62316175 00830002100 62323787 00830002100 62337211 00830002100 62349871 00830002100 62459838 00830002200 11009324 00830002200 62204732 00830002200 62215397 00830002200 62323788 00830002200 62331820 00830002200 62343566 00830002200 62430807 00830002300 62204765 00830002300 62220678 00830002300 62297852 00830002300 62323789 00830002300 62323794 00830002300 62331822 00830002300 62349872 00830002300 62357512 00830002300 62419528 00830002400 62208151 00830002400 62264855 00830002400 62316178 00830002400 62323790 00830002400 62343567 00830002400 62349873 00830002400 62405298 00830002500 62204734 00830002500 62215398 00830002500 62316176 00830002500 62323792 00830002500 62331823 00830002500 62337217 00830002500 62357513 00830002600 62239781 00830002600 62305744 00830002600 62316179 00830002600 62323796 00830002600 62337220 00830002600 62349874 00830002600 62393802 00830002600 62428995
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Descripción del producto
    Zimmer Trabecular Metal Total Ankle Talar Component Right 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.
Device Recall Zimmer Trabecular Metal" Total Ankle Tibial Base and Talar Components
  • Modelo / Serial
    Part Number Lot Number 00450004100 62143211 00450004100 62215399 00450004100 62226572 00450004100 62239797 00450004100 62248808 00450004100 62285639 00450004100 62290853 00450004200 62143212 00450004200 62208157 00450004200 62208158 00450004200 62215401 00450004200 62220683 00450004200 62226573 00450004200 62248809 00450004200 62267650 00450004200 62285554 00450004200 62299545 00450004200 62393808 00450004200 62416048 00450004200 62419541 00450004300 62143213 00450004300 62160229 00450004300 62208159 00450004300 62215402 00450004300 62220681 00450004300 62220684 00450004300 62267645 00450004300 62279057 00450004300 62285555 00450004300 62285556 00450004300 62305745 00450004300 62305746 00450004300 62310757 00450004300 62349877 00450004300 62357515 00450004300 62368389 00450004300 62378070 00450004300 62397422 00450004300 62409042 00450004300 62416049 00450004300 62419542 00450004300 62442239 00450004300 62453785 00450004400 62168364 00450004400 62208160 00450004400 62215403 00450004400 62220686 00450004400 62232378 00450004400 62267647 00450004400 62297853 00450004400 62299546 00450004400 62299547 00450004400 62299548 00450004400 62343569 00450004400 62349879 00450004400 62372420 00450004400 62393809 00450004400 62397423 00450004400 62405323 00450004400 62409043 00450004500 62143215 00450004500 62215404 00450004500 62220688 00450004500 62232379 00450004500 62248810 00450004500 62254967 00450004500 62279058 00450004500 62299549 00450004500 62368390 00450004500 62378071 00450004600 62143216 00450004600 62239795 00450004600 62239796 00450004600 62248811 00450004600 62254968 00450004600 62285640 00450004600 62290855 00450004600 62405325 00830004100 62208152 00830004100 62316180 00830004100 62363978 00830004200 62204737 00830004200 62226574 00830004200 62239798 00830004200 62316181 00830004200 62337230 00830004200 62375878 00830004300 62204736 00830004300 62226575 00830004300 62232380 00830004300 62297854 00830004300 62323804 00830004300 62343570 00830004300 62372421 00830004300 62439685 00830004400 62204738 00830004400 62226576 00830004400 62232381 00830004400 62267658 00830004400 62323802 00830004400 62337231 00830004400 62375879 00830004500 62204739 00830004500 62232382 00830004500 62310759 00830004500 62331825 00830004500 62363980 00830004600 62239782 00830004600 62331826 00830004600 62357516
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • Descripción del producto
    Zimmer Trabecular Metal Total Ankle Tibial Base Component 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.
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