Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61774117 62141262 62193298 62251564 62261955 61672554 61672555 61672558 61774118 61774119 61774120 61827109 61827110 61827111 61863080 61863081 61863083 61863084 61863085 61912434 61915370 61915371 61979021 61979022 61979023 62016175 62020276 62041296 62060610 62069533 62091728 62141255 62141256 62141257 62155305 62155306 62155307 62177111 62214660 62214661 62214662 62214663 62214664 62251565 62251566 62271420 62298567 62315723 62319301 62326315 62337922 62337923 61442295 61672561 61672562 61721670 61774134 61774135 61774136 61774137 61774140 61774141 61774142 61827112 61827113 61827114 61827115 61827116 61863088 61863090 61863091 61863093 61863094 61898777 61898778 61898779 61898780 61898781 61912437 61914863 61914864 61914865 61934678 61934679 61934680 61934681 61934682 61958855 61958856 61958857 61958858 61979024 61979025 61979026 61979027 61993771 61993773 61993774 61993775 61993776 62022557 62029925 62029926 62029927 62037892 62041300 62041301 62041302 62060611 62060612 62064931 62064932 62064933 62069538 62077846 62077847 62077848 62080358 62080359 62080360 62143198 62143199 62143201 62143601 62143602 62143603 62168181 62168182 62193299 62193301 62193302 62193303 62200277 62200278 62200279 62214665 62214666 62214667 62214668 62214669 62227415 62227416 62227417 62271422 62271423 62271424 62271425 62271426 62284606 62284607 62284608 62298568 62298569 62319299 62326502 62326503 62332546 62332547 62335852 62335864 62345560 62357204 62357205 61774143 61774144 61774145 61774146 61774147 61774148 61827117 61827118 61827119 61863112 61863113 61863114 61863115 61863116 61912438 61914866 61914867 61914868 61914869 61934684 61934685 61934686 61934687 61958859 61958860 61958861 61979028 61979029 61979030 62016156 62016157 62016158 62022554 62022555 62029928 62029929 62029930 62041303 62041304 62060613 62060614 62064935 62064936 62077849 62077850 62077851 62143194 62143195 62143196 62143197 62143604 62143605 62143606 62143607 62168183 62168184 62193304 62193305 62193306 62200285 62200286 62214670 62214671 62214672 62227418 62227419 62261960 62261961 62261962 62261963 62261964 62261966 62315724 62319295 62319296 62319297 62326311 62326312 62332564 62332565 62345558 62345559 62358488 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 61774178 61774179 61774180 61774181 61774182 61774183 61863148 61863149 61863150 61863151 61863152 61912439 61934688 61934689 61935101 61935102 61979031 61979032 61979033 62016160 62016162 62022559 62037894 62037895 62051524 62051525 62069546 62089014 62089015 62143608 62168185 62177112 62193308 62200281 62200282 62200283 62214674 62214675 62227420 62261968 62261972 62261973 62261975 62298570 62332566 62352641 62358491 62358492 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 61827120 61827121 61827122 61979040 61979041 62051526 62091729 62200288 62227423 62251572 62330688 62029931
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 50 consists of all product under product code: JWH and same usage: || Item no: || 595002701 NEXGEN MIS TIBIA PLATE PR || 595002702 NEXGEN MIS TIBIA PLATE PR || 595003701 NEXGEN MIS TIBIA PLATE PR || 595003702 NEXGEN MIS TIBIA PLATE PR || 595003712 NEXGEN MIS TIBIA PLATE PR || 595004701 NEXGEN MIS TIBIA PLATE PR || 595004702 NEXGEN MIS TIBIA PLATE PR || 595005701 NEXGEN MIS TIBIA PLATE PR || 595005702 NEXGEN MIS TIBIA PLATE PR || for use in total knee 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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