Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61986559 61986661 62332485 62339373 62339372 61674407 61953445 62048819 62308513 62326387 62326389 62044206 62332484 62339371 61623552 61623554 61661363 61667818 61667821 61825066 61881292 61968207 61968208 61968209 61968210 61968212 61968213 61996180 61996181 62011506 62032192 62073694 62163394 62163395 62176480 62176481 62176482 62176484 62176485 62176490 62194287 62194288 62194295 62227248 62292597 62292598 62292599 62292600 62292601 62292602 62318725 62318726 62318818 62319085 62332482 62337854 62337855 62352228 62352230 62163394N 62319085N 61623693 61661367 61667833 61667834 61674415 61674417 61801347 61801351 61836013 61836017 61836018 61868984 61874772 61874773 61878940 61878943 61878944 61878945 61885304 61885305 61890085 61890088 61908410 61908411 61929734 61929741 61929742 61929743 61943261 61943264 61948726 61948727 61953452 61953456 61953457 61974150 61974152 61974156 61974158 61980039 61980040 61980044 61980045 61983076 61983077 61983078 61996185 62011509 62011510 62011511 62011512 62011513 62016785 62021129 62021130 62021131 62021136 62032195 62073698 62089906 62089907 62089908 62090517 62090524 62110368 62110369 62110370 62163402 62163405 62163409 62163414 62176499 62176508 62188030 62188031 62188034 62188035 62194296 62194297 62194301 62194302 62211380 62221233 62256198 62256201 62256202 62256203 62256204 62256206 62256207 62256208 62256209 62256210 62256211 62256212 62256213 62256214 62256215 62256216 62292603 62292604 62292605 62292606 62292607 62292608 62292609 62292610 62292611 62292612 62292613 62292614 62313348 62313349 62313350 62313351 62318720 62318721 62318812 62318813 62318814 62318815 62319087 62326321 62326322 62326323 62326324 62326563 62326564 62332479 62332480 62337844 62337845 62337847 62337848 62346362 62346376 62346377 62358307 62292607N 62292614N 62318814N 62326323N 62326563N 61636597 61674423 61674429 61801376 61836030 61836037 61878952 61881303 61881304 61881595 61881596 61881598 61881602 61881608 61881609 61881610 61890092 61890094 61900773 61900774 61900775 61911775 61911779 61922544 61922545 61922547 61926496 61926509 61926512 61929756 61929757 61929758 61929759 61953461 61953462 61953463 61961135 61961137 61961138 61961144 61961145 61961147 61974162 61974168 61980048 61980050 61980053 61983083 61983084 61983085 61983086 61983087 61996189 61996190 61996191 61996192 61996193 61996194 61996195 61996196 61996198 61999329 61999330 61999331 61999333 61999334 61999335 61999336 61999337 62011516 62011517 62011520 62011521 62011522 62011523 62011524 62011525 62011526 62011527 62011528 62016767 62016768 62016769 62016770 62016771 62016772 62016773 62016774 62016775 62016788 62016789 62016790 62016794 62016795 62021143 62021144 62021146 62021148 62021150 62021152 62021156 62021158 62021160 62021161 62037911 62037918 62037919 62044217 62061701 62061704 62061706 62069604 62069606 62069607 62069608 62069610 62069611 62073186 62080986 62090538 62110374 62119803 62126630 62126632 62136803 62136805 62136806 62157214 62161148 62161151 62163425 62163427 62176514 62176518 62176519 62176521 62188051 62188053 62192730 62194311 62194313 62202264 62211385 62211392 62221216 62221217 62221218 62227299 62244049 62256245 62256246 62256247 62256248 62256249 62266791 62266792 62266793 62266794 62266795 62266796 62266797 62266798 62266799 62266803 62266804 62266805 62266806 62266808 62266809 62266810 62266811 62266812 62266813 62266814 62266815 62273266 62273267 62273268 62273269 62273270 62273271 62273272 62273293 62273294 62273295 62273296 62273297 62273298 62273299 62273301 62273302 62273303 62273304 62292615 62292616 62292617 62292618 62292619 62292621 62292622 62292623 62292624 62292625 62292626 62292627 62292628 62313345 62313346 62313347 62316822 62316823 62316824 62318710 62318711 62318712 62318713 62318807 62318808 62318809 62318810 62318811 62326361 62326362 62326363 62326364 62332458 62332459 62332460 62332461 62332462 62332463 62332464 62332465 62332466 62337827 62337828 62337829 62337831 62346369 62346370 62352220 62352222 62358220 62358221 62358222 62358223 62358224 62358225 62358226 62358227 62363416 62292615N 62292621N 62318809N 62318811N 62332463N 62337827N 62337829N 61623755 61636619 61667843 61667844 61667845 61667846 61667850 61674437 61674438 61674439 61674440 61674441 61674442 61674443 61674444 61674445 61674447 61674448 61687194 61687198 61868997 61874781 61874784 61878959 61878960 61878962 61881313 61881316 61881611 61881612 61898885 61898887 61898888 61898889 61898890 61898891 61898892 61898893 61898894 61898895 61911541 61911548 61911549 61911550 61911784 61920601 61920602 61920603 61920605 61926518 61926519 61926521 61948747 61953475 61953480 61961151 61961153 61961155 61961160 61974172 61974173 61974175 61980055 61980056 61980057 61980061 61980062 61980063 61980065 61983088 61983089 61983093 61996209 61996212 61996214 61996215 61996217 61996218 61999338 61999340 61999341 61999342 61999343 61999344 61999345 61999346 61999347 61999348 61999350 61999351 61999353 61999354 61999355 61999356 61999357 61999358 62011530 62011531 62011532 62011534 62011535 62011536 62011537 62011538 62016776 62016778 62016779 62016780 62016781 62016782 62021167 62021171 62021172 62021173 62021174 62021175 62021185 62021187 62021188 62021189 62021190 62021191 62021192 62032202 62032204 62032209 62032210 62032211 62032212 62032213 62032217 62048598 62061719 62061720 62061721 62061724 62073699 62073702 62073705 62090551 62090558 62110378 62110387 62119835 62119836 62130737 62157226 62161155 62161158 62161160 62163437 62163456 62163457 62176524 62176527 62188065 62188071 62188072 62188073 62188075 62188077 62188081 62188082 62188083 62194320 62194321 62194322 62211401 62211402 62211403 62211410 62211412 62227320 62239408 62244027 62244032 62249785 62249786 62249787 62249788 62249789 62249790 62249793 62249796 62249797 62249798 62249799 62266755 62266756 62266757 62266758 62266759 62266760 62266761 62266762 62266763 62266764 62266765 62266766 62266767 62266768 62266769 62273305 62273306 62273307 62273308 62273309 62273310 62273311 62273312 62273313 62292629 62292630 62292631 62292632 62292633 62292634 62292635 62292636 62292637 62292638 62292639 62292640 62292641 62292642 62316826 62316828 62316829 62318706 62318707 62318708 62318709 62318796 62318797 62318798 62318799 62318801 62318802 62318803 62318804 62318805 62318806 62326333 62326334 62326336 62326338 62332467 62332468 62332469 62332470 62332471 62332472 62332473 62332474 62332475 62337832 62337833 62337834 62337835 62337836 62346371 62346372 62346373 62346374 62346375 62358212 62358213 62358214 62358215 62358216 62358217 62358218 62358219 62363422 62363423 62363426 62363427 62316826N 62318801N 62326334N 62332470N 61623804 61623830 61623832 61623835 61667857 61674457 61674458 61674459 61674460 61680460 61801668 61868999 61878971 61920616 61943275 61943278 61948758 61961167 61961169 61961170 61961171 61961173 61961174 61974180 61974186 61974188 61980066 61980067 61983094 61983096 61983098 61983099 62021193 62037926 62037927 62061727 62061728 62061730 62116848 62116850 62116852 62120705 62120706 62130742 62138894 62138895 62149027 62149028 62149029 62149030 62149031 62149032 62163463 62163466 62163467 62194328 62194330 62211427 62211429 62211432 62221241 62227326 62227327 62239413 62249769 62266770 62266771 62266772 62266773 62266774 62266775 62266776 62266777 62266778 62266779 62266780 62266781 62266782 62266783 62266784 62266785 62266786 62266787 62266788 62266789 62299276 62299280 62326356 62326357 62326358 62326359 62332476 62332477 62332478 62337839 62337840 62337841 62337842 62337843 62346363 62346366 62346367 62363430 62363432 62299280N 62326356N 62326359N 61585184 61585187 61667867 61674461 61929784 61929785 61953497 61953498 61953499 61983101 61996225 61996227 61996228 62005146 62005147 62005148 62005149 62005150 62005151 62005158 62005159 62005160 62021194 62037932 62037934 62037935 62037937 62061743 62069620 62073996 62090567 62090571 62090573 62161139 62163469 62163473 62204959 62227596 62227597 62227601 62249810 62286112 62286113 62286114 62286115 62286116 62286117 62313352 62313353 62313354 62313355 62318714 62318715 62318816 62318817 62326366 62326367 62332481 62337851 62337852 62337853 62346383 62326367N 61573707 61667868 61667869 61667870 61674465 61840693 61840694 61840695 61840696 61840697 61911830 61920627 61926532 61953505 61983106 61983107 61983108 61983109 61983110 61986553 61986555 61986556 61986557 61986558 61996229 61996230 61996231 62021196 62021197 62021198 62021199 62037938 62037939 62048829 62163474 62163475 62176573 62176575 62176576 62249817 62249825 62292594 62292595 62292596 62326369 62326370 61836058 61911849 61929792 62286110 62286111 61926593
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 17 consists of all product under product code: LPH and same usage: || Item no: || 625004515 BONE SCREW 4.5X15 SELF-TA || 625004520 BONE SCREW 4.5X20 SELF-TA || 625004525 BONE SCREW 4.5X25 SELF-TA || 625004530 BONE SCREW 4.5X30 SELF-TA || 625004535 BONE SCREW 4.5X35 SELF-TA || 625004540 BONE SCREW 4.5X40 SELF-TA || 625004550 BONE SCREW 4.5X50 SELF-TA || 625006515 BONE SCREW 6.5X15 SELF-TA || 625006520 BONE SCREW 6.5X20 SELF-TA || 625006525 BONE SCREW 6.5X25 SELF-TA || 625006530 BONE SCREW 6.5X30 SELF-TA || 625006535 BONE SCREW 6.5X35 SELF-TA || 625006540 BONE SCREW 6.5X40 SELF-TA || 625006550 BONE SCREW 6.5X50 SELF-TA || 625006560 BONE SCREW 6.5X60 SELF-TA || 625006570 BONE SCREW 6.5X70 SELF-TA || Product Usage: || For use in total or hemi 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)
    Catalog TMT4B10: Lot 61840378, 61960160, 61967093, 61982587
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog # TMT4B11: Lot 61926103, 61960168, 61967139, 61978064, 61989032
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog TMT4B13, lot 61926106, 61960169, 61967140, 61973165, 61985653
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog TMM4B10, lot 6197019, 61971479, 61960143, 6180365, 6184063
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    Catalog TMM4B11, lot 61926101, 61926107, 61960149, 619267162, 61992706
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Germany, Italy, France Egypt, Spain, Russia, Bulgaria, Turkey, Israel, UAE and CANADA
  • 제품 설명
    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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