Devices

Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat

  • 모델명 / 제조번호(시리얼번호)
    Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

제조사

Zimmer, Inc.
  • 제조사 주소
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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

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Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 2, includes the following Lot numbers: 37214650 61417415 61417416 61442278 61459938 61459939 61459940 61488069 61497510 61497511 61518148 61518149 61538023 61543972 61543973 61543974 61567335 61592049 61592050 61627189 61627190 61672554 61672555 61672556 61672557 61672558 61682128 61682129 61721665 61721666 61721667 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 62345561 62345562 62377649 62383365 62411732 62411733 62411735 62411736 62411737 62586465 62586467 62610913 62610914 62640980 62646141 62646142
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 3, includes the following Lot numbers: 370316 37214039 61414610 61414611 61442294 61442295 61442296 61442297 61450963 61450964 61450965 61454951 61454952 61454953 61459941 61459942 61475123 61475124 61488064 61488065 61488066 61488067 61488068 61497512 61497513 61507223 61507224 61518151 61518153 61518154 61526398 61526399 61558358 61558359 61558360 61558361 61567336 61567337 61567338 61567339 61592084 61592085 61592086 61592087 61627191 61627192 61627193 61627194 61627195 61627196 61627197 61627198 61627199 61627201 61627202 61643928 61643929 61643930 61643931 61643932 61658872 61658873 61658874 61658875 61658876 61658877 61672561 61672562 61672563 61672564 61672565 61672566 61721668 61721669 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 62352633 62352634 62357204 62357205 62377654 62377655 62383356 62383357 62389590 62389591 62389592 62423838 62423839 62423840 62454586 62454587 62460233 62460234 62462894 62462895 62465729 62465730 62465731 62473291 62473292 62473294 62525438 62525439 62525440 62528591 62528592 62528593 62528594 62528595 62610905 62610906 62610907 62610908 62610909 62640971 62640972 62640973 62640974 62640975 62646143 62646144 62646145 62649650 62649652 62649653 62649655
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208 61488209 61488210 61488211 61518162 61518163 61518164 61526401 61538046 61543975 61543976 61558363 61567340 61567341 61567342 61567343 61592088 61592089 61627203 61627204 61627205 61627206 61643933 61643934 61658878 61658879 61658880 61658881 61658882 61678232 61678233 61682153 61682154 61682155 61692238 61692240 61721671 61721672 61721673 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 62358490 62363649 62377650 62383363 62383364 62390066 62390067 62390068 62454576 62454577 62454578 62465724 62465725 62465726 62473212 62473213 62473215 62528582 62528583 62586506 62586507 62586509 62586510 62586518 62610915 62610916 62640976 62640977 62640978 62640979 62646146 62646147 62649656 62649658
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
Device Recall NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, P...
  • 모델명 / 제조번호(시리얼번호)
    Size 4+, includes the following Lot numbers: 61424996 61459959 61475129 61538052 61563971 61573791 61573792 61592090 61627207 61685463 61721674 61774165 61863139 61870152 61934692 61935096 61979044 61979045 62020278 62064940 62091727 62214673 62251567 62251568 62319307 62337924 62369795 62401020 62423841 62436412 62471736 62602816 62646169
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
  • 제품 설명
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
  • Manufacturer
    Zimmer, Inc.
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