Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791 62406803 61815148 62080364 62154619 62180252 62193580 62193581 62226821 62226822 62241155 62241156 62251113 62268508 62316411 62383755 62383757 62396134 62402112 62406794 62402123 62213294 62215054 62396142 62406786 62354792 62406804 62233572 62406807 62163545 62395778 62202292 62241114 62198725 62226816 62241115 62268495 62389251 62389252 62198722 62218184 62268496 62395770 62406805 62218185 62277521 62395775 62406812 62395776 62281868
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 47 consists of all product under product code: LPH and same usage: || Item no: || 611004022 MODULAR CUP 10 DEGREE LIN || 611004428 MODULAR CUP 10 DEGREE LIN || 611004628 MODULAR CUP 10 DEGREE LIN || 611004828 MODULAR CUP 10 DEGREE LIN || 611004832 MODULAR CUP 10 DEGREE LIN || 611005028 MODULAR CUP 10 DEGREE LIN || 611005032 MODULAR CUP 10 DEGREE LIN || 611005628 MODULAR CUP 10 DEGREE LIN || 611005632 MODULAR CUP 10 DEGREE LIN || 611005828 MODULAR CUP 10 DEGREE LIN || 611005832 MODULAR CUP 10 DEGREE LIN || 611006028 MODULAR CUP 10 DEGREE LIN || 611006032 MODULAR CUP 10 DEGREE LIN || 611006228 MODULAR CUP 10 DEGREE LIN || 611006232 MODULAR CUP 10 DEGREE LIN || 611006428 MODULAR CUP 10 DEGREE LIN || 611006432 MODULAR CUP 10 DEGREE LIN || 611006628 MODULAR CUP 10 DEGREE LIN || 611006832 MODULAR CUP 10 DEGREE LIN || 611007028 MODULAR CUP 10 DEGREE LIN || 612004626 MODULAR CUP 20 DEGREE LIN || 612004628 MODULAR CUP 20 DEGREE LIN || 612004828 MODULAR CUP 20 DEGREE LIN || 612004832 MODULAR CUP 20 DEGREE LIN || 612005028 MODULAR CUP 20 DEGREE LIN || 612005032 MODULAR CUP 20 DEGREE LIN || 612005628 MODULAR CUP 20 DEGREE LIN || 612005828 MODULAR CUP 20 DEGREE LIN || 612005832 MODULAR CUP 20 DEGREE LIN || 612006028 MODULAR CUP 20 DEGREE LIN || 612006032 MODULAR CUP 20 DEGREE LIN || 610504428 MODULAR CUP NEUTRAL LINER || 610504832 MODULAR CUP NEUTRAL LINER || 610505028 MODULAR CUP NEUTRAL LINER || 610505032 MODULAR CUP NEUTRAL LINER || 610505632 MODULAR CUP NEUTRAL LINER || 610505832 MODULAR CUP NEUTRAL LINER || 610506032 MODULAR CUP NEUTRAL LINER || 610506232 MODULAR CUP NEUTRAL LINER || For use in total hip arthroplasty
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 제조사 모회사 (2017)
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 263 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    FEM COND BUTTRESS PLT, RT.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    DIST LAT FEM LOCK PLT, RT
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
  • 제품 설명
    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
하나 더 258 건 더