NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" 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-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces."

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: 00-5960-011-31 00-5960-011-32 00-5960-012-31 00-5960-012-32 00-5960-013-31 00-5960-013-32 00-5960-014-31 00-5960-014-32 00-5960-015-31 00-5960-015-32 00-5960-016-31 00-5960-016-32 00-5960-017-31 00-5960-017-32 00-5964-012-01 00-5964-012-02 00-5964-013-01 00-5964-013-02 00-5964-014-01 00-5964-014-02 00-5964-015-01 00-5964-015-02 00-5964-016-01 00-5964-016-02 00-5964-017-01 00-5964-017-02 Lot numbers: 11003819 11003822 11003824 11003955 11003973 11003997 11004030 11004042 11004076 11004086 11004103 11004104 11004105 11004160 11004166 11004173 11004174 11004188 11004190 11004223 11004252 11004255 11004271 11004280 11004300 11004336 11004373 11004377 11004469 11004503 11004546 11004552 11004559 11004565 11004598 11004628 11004629 11004630 11004654 11004675 11004680 11004682 11004706 11004716 11004721 11004722 11004723 11004755 11004756 11004759 11004767 11004768 11004793 11004795 11004821 11004871 11004899 11004901 11004902 11004947 11004949 11004973 11005024 11005026 11005029 11005058 11005063 11005064 11005085 11005098 11005102 11005114 11005123 11005133 11005146 11005154 11005198 11005205 11005213 11005223 11005241 11005271 11005278 11005319 11005321 11005331 11005335 11005336 11005340 11005344 11005377 11005378 11005379 11005382 11005438 11005445 11005477 11005488 11005556 11005562 11005572 11005575 11005578 11005580 11005592 11005596 11005614 11005631 11005664 11005665 11005671 11005679 11005681 11005689 11005706 11005714 11005716 11005717 11005726 11005730 11005733 11005739 11005751 11005754 11005765 11005770 11005778 11005780 11005784 11005785 11005798 11005802 11005803 11005818 11005819 11005861 11005866 11005867 11005869 11005892 11005909 11005915 11005964 11005979 11005981 11005983 11006022 11006047 11006053 11006057 11006064 11006066 11006079 11006080 11006120 11006152 11006156 11006177 11006184 11006185 11006195 11006208 11006241 11006246 11006247 11006260 11006261 11006317 11006318 11006330 11006349 11006358 11006369 11006370 11006387 11006390 11006405 11006440 11006454 11006460 11006461 11006463 11006464 11006469 11006473 11006474 11006484 11006487 11006500 11006505 11006524 11006549 11006563 11006574 11006577 11006579 11006580 11006581 11006592 11006616 11006648 11006672 11006687 11006711 11006734 11006741 11006742 11006754 11006762 11006794 11006801 11006808 11006829 11006838 11006853 11006865 11006889 11006934 11006948 11006950 11006985 11007016 11007041 11007042 11007059 11007069 11007071 11007075 11007076 11007077 11007089 11007091 11007102 11007110 11007111 11007129 11007131 11007132 11007134 11007162 11007178 11007230 11007264 11007265 11007269 11007302 11007304 11007325 11007349 11007366 11007377 11007387 11007395 11007396 11007408 11007412 11007437 11007456 11007458 11007480 11007496 11007506 11007515 11007682 11400098 11400100 11400115 11400153 11400154 11400166 11400171 11400175 11400184 11400191 11400243 11400263 11400273 11400276 11400277 11400285 11400288 11400290 11400294 11400308 11400309 11400320 11400324 11400328 11400333 11400344 11400346 11400349 11400350 11400366 11400380 11400385 11400387 11400392 11400405 11400429 11400435 11400443 11400447 11400462 11400463 11400467 11400469 11400474 11400480 11400485 11400491 11400498 11400501 61417634 61417635 61417636 61417637 61417981 61417986 61417987 61418002 61418003 61418004 61776947 61782238 61782262 61782267 61782275 61782296 61782304 61782305 61782315 61782330 61782346 61782348 61789179 61789181 61789185 61789187 61789189 61789209 61789211 61789212 61789213 61789216 61789217 61789218 61789219 61789220 61789221 61789222 61789223 61789224 61789225 61789227 617

Risk classification

Class II

Area (FDA)

device

Country

United States