NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."

Recall details

Manufacturer

Zimmer Biomet, Inc.

Distributor

Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada

Lot

Item numbers: 00-5970-011-31 00-5970-011-32 00-5970-012-31 00-5970-012-32 00-5970-013-31 00-5970-013-32 00-5970-013-33 00-5970-013-34 00-5970-014-31 00-5970-014-32 00-5970-014-33 00-5970-014-34 00-5970-015-31 00-5970-015-32 00-5970-015-33 00-5970-015-34 00-5970-016-31 00-5970-016-32 00-5970-017-31 00-5970-017-32 00-5970-018-31 00-5970-018-32 00-5972-011-31 00-5972-011-32 00-5972-012-31 00-5972-012-32 00-5972-013-33 00-5972-013-34 00-5972-014-33 00-5972-014-34 00-5972-015-33 00-5972-015-34 00-5972-016-31 00-5972-016-32 00-5972-017-31 00-5972-017-32 00-5972-018-31 00-5972-018-32 Lot numbers: 11003380 11003415 11003477 11003574 11003583 11003586 11003597 11003601 11003602 11003612 11003613 11003626 11003644 11003666 11003673 11003832 11003870 11003871 11003889 11003890 11003893 11003941 11003942 11003954 11004035 11004058 11004080 11004189 11004302 11004500 11004566 11004597 11004683 11004766 11004817 11004868 11004869 11004870 11004946 11004950 11004952 11004954 11004957 11004958 11004972 11004980 11005018 11005054 11005068 11005096 11005100 11005232 11005248 11005320 11005328 11005374 11005425 11005444 11005461 11005491 11005561 11005594 11005629 11005632 11005647 11005674 11005677 11005678 11005685 11005697 11005707 11005747 11005795 11005796 11005820 11005891 11005911 11006035 11006059 11006084 11006245 11006248 11006249 11006316 11006332 11006362 11006365 11006403 11006458 11006471 11006538 11006588 11006605 11006607 11006631 11006640 11006670 11006718 11006728 11006736 11006738 11006792 11006810 11006812 11006828 11006877 11006926 11006963 11007047 11007070 11007080 11007161 11007163 11007179 11400178 11400200 11400224 11400230 11400233 11400234 61768186 61777574 61777575 61777578 61777590 61777594 61777595 61777597 61782669 61782670 61782671 61782672 61782673 61782674 61782675 61782676 61782677 61782678 61782679 61782680 61782833 61782834 61782835 61782836 61782837 61782838 61788717 61788718 61788719 61788720 61788721 61788722 61788723 61788724 61788726 61788727 61788728 61788729 61795791 61795792 61795793 61795794 61795795 61795796 61795797 61795798 61795807 61795808 61795809 61795814 61795815 61795816 61795817 61795818 61795819 61795820 61795821 61800641 61800642 61800643 61800644 61800645 61800646 61800647 61800648 61800717 61800718 61800719 61800720 61800721 61800722 61800723 61800724 61800725 61800726 61800727 61800728 61805238 61805239 61805240 61805241 61805242 61805243 61805526 61805527 61805528 61805529 61805530 61805531 61805532 61805533 61805534 61805535 61805536 61805537 61805538 61805539 61810123 61810124 61810125 61810126 61810127 61810128 61810143 61810144 61810145 61810146 61810147 61810149 61810150 61810151 61810152 61810153 61810154 61810155 61810156 61810157 61815445 61815446 61815447 61815449 61815450 61815451 61822292 61822293 61822296 61822298 61822299 61822301 61822302 61824578 61824579 61824580 61824581 61824582 61824583 61824588 61824589 61831603 61831604 61831605 61831606 61831607 61831608 61831651 61831653 61836498 61836499 61836501 61836502 61836528 61836529 61836530 61836531 61846150 61846151 61846152 61846153 61846154 61846155 61846156 61846157 61846158 61846176 61846177 61846178 61846179 61846180 61846181 61848524 61848525 61848526 61848527 61848528 61848529 61848530 61848535 61848536 61848537 61848538 61855538 61855539 61855540 61855541 61855542 61855543 61855544 61855545 61855546 61857319 61857320 61857321 61857322 61857323 61857325 61857326 61857352 61857354 61857355 61857356 61857357 61861726 61861727 61861728 61861729 61861730 61861731 61861733 61862137 61862138 61862170 61862171 61862172 61862173 61862174 61862175 6

Risk classification

Class II

Area (FDA)

device

Country

United States