Device Recall Persona TASP

  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517200410 42517200510 42517200610 42517200710  Lot Numbers:  62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || UC Tibial Articular Surface Provisional Top || Nonsterile || TASP UC L 3-7 CD TOP || TASP UC L 4-11 EF TOP || TASP UC L 7-12 GH TOP || TASP UC L 9-12 J TOP
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517400410 42517400510 42517400610 42517400710 42517400810 42517400910 42517401010 Lot Numbers:  62043556 62110045 62121489 62125589 62147235 62168383 62177247 62165546 62311021 62314722 62386421 62442838 62525491 62558585 62605208 62627292 62683432 62696865 62717343 62022344 62041351 62073566 62104372 62117744 62121488 62149175 62187324 62187325 62247351 62311022 62314723 62364961 62391117 62436468 62474903 62538403 62564311 62611089 62669905 62690895 62720225 62020946 62028233 62073570 62110047 62130976 62187327 62187329 62189325 62290822 62305407 62314724 62386424 62420258 62469459 62531662 62565041 62551356 62584447 62612266 62687089 62690049 62690909 62702763 62724739 62022345 62024978 62104374 62124040 62134006 62200223 62200224 62233921 62294595 62314725 62385328 62436479 62511942 62544381 62565042 62597795 62669933 62696869 62710618 62043559 62104415 62121530 62203396 62203397 62314728 62314730 62356529 62390841 62442847 62511926 62565057 62551396 62595859 62654933 62656069 62720226 62034569 62055683 62113088 62130978 62149714 62165547 62168384 62177253 62184260 62256285 62256284 62397161 62420223 62511956 62565108 62551402 62601570 62696376 62043561 62055684 62116593 62152728 62145793 62166196 62166195 62168385 62184261 62239294 62319851 62320878 62356546 62390865 62474905 62538415 62565044 62581863 62622558 62632819 62740693 62398035 62440437 62515479 62515499 62563803 62581853 62675491
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || PS Tibial Articular Surface Provisional Top || Nonsterile || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 3-5 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 6-9 CD TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 3-5 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 6-9 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 10-11 EF TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 6-9 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 GH TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP || TASP PS L 10-12 J TOP
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517000303 42517000313 42517000505 42517000515 42517000707 42517000717 42517000909 42517000919 42527000303 42527000313 42527000505 42527000515 42527000707 42527000717 42527000909 42527000919  Lot Numbers:  62022340 62024973 62062232 62104367 62187314 62187315 62190367 62190370 62265725 62301862 62314675 62385126 62385132 62355857 62403987 62414017 62420244 62456269 62506026 62506044 62531664 62558106 62564325 62596552 62600208 62614790 62683419 62691385 62698730 62716777 62024974 62032099 62075271 62144791 62171682 62171684 62184223 62187317 62239237 62256256 62248153 62386757 62391108 62414001 62391109 62414002 62456271 62474902 62544384 62565107 62565106 62601564 62612269 62627270 62678888 62684675 62695301 62710627 62745014 62019862 62091183 62177238 62177239 62177240 62268818 62282708 62305406 62314683 62351287 62356123 62385455 62401419 62405946 62419059 62429198 62456279 62504887 62531665 62559945 62565049 62595861 62621822 62627202 62663169 62690886 62696853 62698724 62716769 62710616 62030854 62050136 62125572 62154284 62165540 62168382 62177242 62190375 62247344 62247345 62256257 62364951 62391110 62413998 62391111 62427064 62413999 62469454 62525495 62538399 62565110 62565111 62565109 62595858 62630285 62632817 62680122 62680123 62691389 62696886 62710624 62717356 62022342 62024977 62087042 62091198 62165542 62189343 62187321 62233919 62239239 62256279 62247347 62386756 62391114 62391115 62403989 62419057 62429191 62461234 62525494 62544359 62564327 62587605 62601573 62601574 62668825 62696851 62717321 62744886 62747704 62030862 62029578 62125573 62165544 62189323 62189322 62189324 62201539 62239240 62256280 62247349 62372408 62386777 62391226 62403995 62420263 62456272 62506051 62544380 62565113 62565114 62595867 62663132 62668575 62691387 62689234 62717344 62338672 62338673 62338674 62338675 62504658 62511928 62564328 62619534 62383954 62427416 62443506 62495522 62498723 62669167 62710621 62055685 62075277 62149177 62192902 62192903 62198204 62233922 62305408 62356554 62385133 62385134 62404280 62420241 62449201 62515528 62529691 62551363 62564308 62604993 62614838 62616391 62683416 62715142 62715143 62724729 62732162 62043562 62104420 62166222 62196582 62196583 62196584 62233923 62305409 62356575 62356576 62386778 62404281 62427063 62419055 62449190 62497269 62544355 62565097 62565098 62600182 62595870 62608888 62677155 62678897 62696859 62710617 62730175 62043563 62091814 62177255 62188407 62188408 62188409 62233924 62305410 62356580 62356582 62386427 62429080 62429081 62442784 62479530 62480204 62480205 62544357 62544358 62568264 62569954 62592280 62595862 62611084 62641326 62654924 62695307 62710625 62740696 62036671 62125597 62144797 62203401 62203402 62209047 62229714 62239297 62248169 62315063 62356591 62364962 62386780 62391235 62419058 62442845 62469460 62531658 62551097 62568294 62654893 62654894 62663171 62683434 62702755 62055687 62089764 62189328 62209048 62229720 62239303 62290779 62311023 62351301 62315137 62356596 62386781 62391238 62404283 62420245 62449209 62504870 62544366 62565096 62581866 62597790 62608891 62612281 62683418 62686270 62724731 62724732 62046410 62125598 62149716 62187330 62187331 62239305 62239306 62248170 62320808 62356601 62385135 62385136 62404284 62420257 62449213 62504874 62529692 62558587 62581868 62600187 62608890 62627268 62684651 62689233 62690894 62702304 62702306 62710622 62394886 62400296 62428415 62443507 62500932 62500933 62551242 62597759 62660204 62646280 62380844 62399812 62428395 62443504 62493131 62536079 62564309 62632816 62695868
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || Tibial Articular Surface Provisional Bottom || Nonsterile || TASP L CD BOTTOM, +0MM || TASP L CD BOTTOM, +6MM || TASP L EF BOTTOM, +0MM || TASP L EF BOTTOM, +6MM || TASP L GH BOTTOM, +0MM || TASP L GH BOTTOM, +6MM || TASP L J BOTTOM, +0MM || TASP L J BOTTOM, +6MM || TASP R CD BOTTOM, +0MM || TASP R CD BOTTOM, +6MM || TASP R EF BOTTOM, +0MM || TASP R EF BOTTOM, +6MM || TASP R GH BOTTOM, +0MM || TASP R GH BOTTOM, +6MM || TASP R J BOTTOM, +0MM || TASP R J BOTTOM, +6MM
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517000410 Lot Numbers:  62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || CR Tibial Articular Surface Provisional Top || Nonsterile || TASP CR L 3-9 CD TOP
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, 42527600919    Lot Numbers:  62345370 62402721 62423922 62424796 62494665 62563912 62590524 62696878 62717331 62347233 62399612 62428432 62505575 62563917 62592279 62692687 62352330 62416376 62432157 62490790 62563913 62590525 62696881 62357329 62374803 62412999 62432797 62490792 62563911 62654931 62717334 62357328 62372411 62407772 62432794 62463961 62525489 62563914 62575756 62702758 62724743 62358632 62373739 62405896 62432154 62463962 62563916 62656074 62710626 62432790 62462267 62572574 62443455 62456923 62568289 62357865 62410790 62423921 62424804 62500930 62573363 62695299 62347240 62399870 62430403 62504858 62572571 62692683 62732165 62357866 62406970 62432150 62479624 62573364 62695293 62351310 62410788 62435708 62507548 62569955 62698727 62358633 62373740 62410789 62432796 62465722 62517280 62581856 62695873 62363685 62364505 62407568 62432152 62463963 62505999 62572570 62695889 62710608 62432792 62499171 62704629 62445747 62497257
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || Tibial Articular Surface Provisional Bottom || Nonsterile || PSN A/S PROV L CD BOTTOM +0MM || PSN A/S PROV L CD BOTTOM +6MM || PSN A/S PROV L EF BOTTOM +0MM || PSN A/S PROV L EF BOTTOM +6MM || PSN A/S PROV L GH BOTTOM +0MM || PSN A/S PROV L GH BOTTOM +6MM || PSN A/S PROV L J BOTTOM +0MM || PSN A/S PROV L J BOTTOM +6MM || PSN A/S PROV R CD BOTTOM +0MM || PSN A/S PROV R CD BOTTOM +6MM || PSN A/S PROV R EF BOTTOM +0MM || PSN A/S PROV R EF BOTTOM +6MM || PSN A/S PROV R GH BOTTOM +0MM || PSN A/S PROV R GH BOTTOM +6MM || PSN A/S PROV R J BOTTOM +0MM || PSN A/S PROV R J BOTTOM +6MM
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910   Lot Numbers:  62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
  • 제품 설명
    Persona (TM) The Personalized Knee System || CPS Tibial Articular Surface Provisional Top || Nonsterile || TASP MLC L 3-5 CD TOP || TASP MLC L 6-9 CD TOP || TASP MLC L 3-5 EF TOP || TASP MLC L 6-9 EF TOP || TASP MLC L 10-11 EF TOP || TASP MLC L 6-9 GH TOP
  • Manufacturer