Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 61809193 61809203 61809206 61822572 61841518 61844443 61897681 61901015 62001246 62193768 62277477 62277478 62330721 62336479 62345698 62193768N 62277478N 62266680 61880656 62234613 62266684 62266688 62266692 62333353 61622044 62339493 62339495 62330722 61635839 62330724 61782888 61782889 61782891 61809172 61809173 61809184 61822578 61830206 61830207 61830208 61830209 61838593 61838596 61838599 61838602 61838603 61838604 61864057 61867128 61867129 61893770 61893771 61893772 61901018 61934345 61934352 61951304 61951305 61951306 61996677 62001247 62001248 62001249 62043075 62124382 62124383 62124384 62124385 62124386 62140004 62140005 62167136 62167137 62167139 62167140 62172551 62172553 62175521 62175523 62266672 62266673 62266674 62266675 62277480 62277481 62277482 62299139 62299140 62299143 62299146 62299147 62299148 62314147 62314150 62314154 62314158 62336480 62336481 62277480N 62277481N 62299140N 62299147N 62266682 62266686 61880383 62266690 61880385 62266695 62294804 62266697 62299159 62137496 62148988 62158959 62294778 62259834 62284876 62294792 61634097 62259848 62294786 62280715 62330723 62285471 62285470 61801384 61801385 61801389 61822581 61841519 61901019 61996680 61996681 62181505 62181510 62225836 62266670 62266671 62277483 62306208 62311817 62311818 62336483 62336484 62306208N 61809209 61864058 61880655 61939421 62266676 62311819 62336485 62333354 61793329 61939423 61690423 61695534 61777525 61777526 61782870 61782872 61782874 61782876 61782878 61804353 61804354 61804355 61804356 61804357 61804358 61804359 61819365 61819366 61819369 61822544 61822547 61825926 61825927 61825932 61825935 61825936 61825939 61835597 61835598 61835599 61835600 61841520 61841521 61841522 61841523 61844441 61844459 61844460 61852150 61852151 61852153 61852154 61856841 61856844 61867113 61867114 61867115 61867116 61875012 61875013 61875014 61875015 61880647 61880648 61886705 61886708 61886711 61886712 61897683 61897685 61901005 61901006 61901008 61901009 61908425 61908426 61908430 61908433 61908437 61908438 61924247 61924248 61924249 61924250 61924251 61930488 61930489 61930490 61930493 61930494 61930495 61934312 61934316 61934322 61951301 61951302 61951303 61956888 61956889 61956890 61956891 61983801 61983802 61984035 61984037 61984039 61984042 61987560 61987561 62023154 62023155 62023156 62031794 62031796 62043071 62048970 62048971 62048975 62048976 62124375 62124376 62124377 62124379 62137472 62137473 62137474 62137475 62137476 62137477 62137478 62140014 62140015 62140016 62140017 62146533 62146536 62146539 62146542 62178055 62178056 62178057 62188597 62188598 62188599 62188601 62188602 62188607 62188608 62193757 62193760 62193761 62204883 62204884 62204885 62204887 62204889 62204891 62204895 62204896 62210873 62210876 62216852 62216853 62216854 62216855 62216856 62225827 62225828 62225829 62225830 62225831 62225832 62234392 62234394 62234395 62247839 62247850 62247854 62247858 62247862 62256561 62256564 62256565 62271707 62271711 62277463 62277464 62277465 62277466 62277467 62277468 62294815 62294819 62294823 62294826 62302075 62302076 62302077 62306234 62306235 62306236 62311812 62311813 62311814 62311815 62314134 62314135 62314136 62317546 62317552 62317554 62325931 62325932 62325933 62325934 62325935 62325936 62325937 62325938 62330716 62330717 62330718 62330719 62330720 62333355 62333356 62333357 62333358 62333359 62333360 61825927R 61690420 61690421 61700084 61714630 61777527 61777528 61777529 61777530 61777531 61782879 61782881 61782882 61809152 61809153 61809154 61809155 61809158 61822552 61829240 61829245 61829252 61829259 61829260 61835601 61835602 61852147 61852148 61856845 61864050 61867118 61867121 61867122 61867123 61880650 61880651 61886713 61886723 61897679 61908439 61908440 61908441 61920054 61920055 61920056 61934330 61934335 61946393 61946394 61946395 62001235 62001237 62001238 62031797 62031800 62048972 62048974 62137479 62137480 62140010 62140011 62140012 62140013 62146560 62146565 62146567 62196149 62196151 62196153 62196156 62196157 62210901 62216857 62216858 62225833 62225834 62234386 62234387 62234388 62256568 62256569 62263118 62277469 62277470 62277471 62277472 62277473 62306237 62306238 62306239 62314137 62314138 62314142 62317557 62317558 62339497 62339499 62339501 62339502 62339503 62342073 62342074 62342076 62342081 62342085 61714629 61777535 61777537 61782883 61782884 61801382 61801383 61809164 61809167 61809168 61822561 61822564 61829261 61829267 61829268 61829269 61835603 61844461 61852145 61852146 61867127 61880652 61880654 61893766 61893767 61893768 61908442 61908443 61908444 61920057 61920058 61920059 61946396 61946397 61996676 62001241 62001243 62001244 62001245 62023158 62031802 62031806 62043073 62137482 62137483 62137486 62140006 62140007 62140008 62140009 62175075 62175077 62175078 62175082 62193762 62193763 62196159 62196160 62196161 62196162 62196163 62210893 62210897 62210899 62234390 62234391 62262063 62262064 62262066 62263119 62263120 62263121 62263123 62277474 62277475 62277476 62302078 62302079 62306240 62317560 62317561 62317562 61809170 61856846 61893769 61939417 61939418 62031807 62031808 62048973 62137490 62137492 62181017 62181018 62181019 62193764 62193765 62225835 62256555 62256557 62289983 62289984 62317564 62317565 62317569 61809171 61844442 61875011 61897680 61939419 61939420 62181020 62181021 62181022 62193766 62193767 62216859 62256559 62280589 62280590 62311816
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 27 consists of all product under product code: HSB and same usage: || Item no: || 234703104 DISTAL MEDIAL FEMORAL CON || 234703206 DISTAL MEDIAL FEMORAL CON || 234703208 DISTAL MEDIAL FEMORAL CON || 234800504 DISTAL POSTERIOR/LATERAL || 234800506 DISTAL POSTERIOR/LATERAL || 234800508 DISTAL POSTERIOR/LATERAL || 234800510 DISTAL POSTERIOR/LATERAL || 234800604 DISTAL POSTERIOR/LATERAL || 234800606 DISTAL POSTERIOR/LATERAL || 234800608 DISTAL POSTERIOR/LATERAL || 234800610 DISTAL POSTERIOR/LATERAL || 234800614 DISTAL POSTERIOR/LATERAL || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
  • 1 Event

Fabricant

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

  • Modèle / numéro de série
    Catalog TMT4B10: Lot 61840378, 61960160, 61967093, 61982587
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar)
  • Manufacturer
  • Modèle / numéro de série
    Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMT4B13, lot 61926106, 61960169, 61967140, 61973165, 61985653
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMM4B10, lot 6197019, 61971479, 61960143, 6180365, 6184063
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R, www.zimmerdental.com, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
  • Manufacturer
  • Modèle / numéro de série
    Catalog TMM4B11, lot 61926101, 61926107, 61960149, 619267162, 61992706
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • Description du dispositif
    Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx, Sterile R, Zimmer Dental, Carlsbad, CA 92008, USA || The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar.
  • Manufacturer
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