Date Initiated by Firm | January 04, 2017 |
Create Date | January 28, 2017 |
Recall Status1 |
Terminated 3 on June 11, 2018 |
Recall Number | Z-1115-2017 |
Recall Event ID |
75973 |
510(K)Number | K023546 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | Vanguard Total Knee System
Vanguard Open Box Femoral Components
Item Number: 183100
Description: VNGD PS OPEN INTL FEM RT 55
Item Number: 183102
Description: VNGD PS OPEN INTL FEM-RT 57.5
Item Number: 183104
Description: VNGD PS OPEN INTL FEM RT 60
Item Number: 183106
Description: VAN PS OPEN INTL FEM-RT 62.5
Item Number: 183108
Description: VAN PS OPEN INTL FEM-RT 65
Item Number: 183110
Description: VAN PS OPEN INTL FEM-RT 67.5
Item Number: 183112
Description: VAN PS OPEN INTL FEM-RT 70
Item Number: 183113
Description: VAN PS OPEN INTL FEM-RT 72.5
Item Number: 183120
Description: VAN PS OPEN INTL FEM-LT 55
Item Number: 183122
Description: VAN PS OPEN INTL FEM-LT 57.5
Item Number: 183124
Description: VAN PS OPEN INTL FEM-LT 60
Item Number: 183126
Description: VAN PS OPEN INTL FEM-LT 62.5
Item Number: 183128
Description: VAN PS OPEN INTL FEM-LT 65
Item Number: 183130
Description: VAN PS OPEN INTL FEM-LT 67.5
Item Number: 183132
Description: VAN PS OPEN INTL FEM-LT 70
Item Number: 183133
Description: VAN PS OPEN INTL FEM-LT 72.5 |
Code Information |
Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Lot Numbers: J3762496 J3762510 J3778480 J3786204 J3803291 J3812133 J3825051 J3833214 J3838037 J3844255 J3848989 J3762497 J3772688 J3779265 J3786205 J3803292 J3812134 J3825052 J3833215 J3844243 J3844256 J3848991 J3762498 J3773147 J3779266 J3786206 J3807380 J3818045 J3826948 J3833216 J3844244 J3844257 J3848992 J3762500 J3773148 J3781773 J3786207 J3807381 J3818046 J3826949 J3834846 J3844246 J3844258 J3848993 J3762501 J3773149 J3781774 J3786209 J3808161 J3818047 J3826950 J3834847 J3844247 J3844259 J3762502 J3775073 J3781775 J3803285 J3808162 J3819257 J3826951 J3834848 J3844248 J3844260 J3762504 J3775074 J3781777 J3803286 J3810188 J3823556 J3826952 J3834849 J3844250 J3847164 J3762506 J3775075 J3781778 J3803287 J3812129 J3823557 J3826954 J3838032 J3844251 J3847165 J3762507 J3775076 J3781779 J3803288 J3812130 J3823558 J3826958 J3838033 J3844252 J3847166 J3762508 J3778478 J3781781 J3803289 J3812131 J3823559 J3830022 J3838034 J3844253 J3848987 J3762509 J3778479 J3786202 J3803290 J3812132 J3823560 J3830023 J3838035 J3844254 J3848988 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Lot Numbers: J3747463 J3769382 J3778412 J3789356 J3803324 J3824927 J3829964 J3834871 J3842063 J3844275 J3849012 J3750117 J3770471 J3778413 J3792510 J3803325 J3824928 J3829965 J3834872 J3842064 J3844276 J3849013 J3751073 J3770473 J3778414 J3792511 J3803326 J3824929 J3829966 J3834873 J3842065 J3844277 J3849014 J3753286 J3770474 J3779264 J3792512 J3803327 J3824931 J3830619 J3834874 J3842066 J3844278 J3851751 J3753287 J3770475 J3781782 J3792513 J3812135 J3824932 J3830620 J3834875 J3842067 J3844279 J3851752 J3753290 J3772632 J3781783 J3792514 J3815876 J3824933 J3830622 J3834876 J3842068 J3844281 J3851753 J3753293 J3772633 J3783564 J3794919 J3815877 J3824935 J3830623 J3834877 J3844261 J3844282 J3851754 J3753294 J3773111 J3783565 J3794920 J3815878 J3824936 J3830624 J3834878 J3844262 J3844283 J3851755 J3754883 J3773112 J3783566 J3794922 J3823493 J3825382 J3830625 J3838063 J3844264 J3847180 J3854200 J3754884 J3773113 J3783567 J3794923 J3823494 J3825383 J3830626 J3838064 J3844265 J3847181 J3767822 J3759776 J3773114 J3786105 J3794924 J3823495 J3825384 J3830627 J3838065 J3844266 J3847182 J3769381 J3759777 J3773115 J3786106 J3794925 J3823496 J3825385 J3834861 J3838066 J3844267 J3847183 J3786109 J3759778 J3774964 J3786108 J3797382 J3823498 J3825386 J3834862 J3838067 J3844268 J3847184 J3786111 J3759779 J3774965 J3786110 J3797383 J3823507 J3826849 J3834863 J3838068 J3844269 J3847185 J3824923 J3759780 J3774966 J3786112 J3797384 J3823509 J3826850 J3834864 J3838069 J3844270 J3849007 J3830621 J3759781 J3774967 J3786113 J3797385 J3823958 J3826851 J3834866 J3838070 J3844271 J3849008 J3854201 J3767820 J3778409 J3789352 J3800697 J3824920 J3826852 J3834867 J3838071 J3844272 J3849009 J3767821 J3778410 J3789353 J3800698 J3824924 J3826853 J3834869 J3838073 J3844273 J3849010 J3769380 J3778411 J3789355 J3803323 J3824926 J3826854 J3834870 J3842061 J3844274 J3849011 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Lot Numbers: J3750489 J3768913 J3775033 J3778469 J3786147 J3794891 J3804117 J3823501 J3830628 J3842087 J3858657 J3753257 J3768917 J3778439 J3778470 J3786149 J3794893 J3804118 J3823502 J3830629 J3842088 J3758396 J3754874 J3768919 J3778440 J3778471 J3786150 J3794896 J3804119 J3824971 J3833232 J3844311 J3772662 J3754877 J3769312 J3778441 J3779286 J3787563 J3794898 J3804120 J3824972 J3833233 J3844312 J3775029 J3757672 J3769313 J3778442 J3779287 J3787565 J3794899 J3804121 J3824974 J3833234 J3844315 J3786137 J3758399 J3769314 J3778443 J3779289 J3787567 J3794900 J3807700 J3824975 J3833235 J3844316 J3787566 J3758400 J3769315 J3778444 J3779291 J3789373 J3794901 J3807701 J3824976 J3834880 J3847186 J3789377 J3758403 J3769316 J3778445 J3779292 J3789374 J3794902 J3807702 J3824977 J3834881 J3847187 J3794562 J3758490 J3769317 J3778446 J3779293 J3789375 J3797360 J3807703 J3824978 J3834883 J3847188 J3794563 J3759910 J3769318 J3778447 J3779294 J3789376 J3797361 J3807704 J3825387 J3834885 J3847189 J3794895 J3759914 J3769319 J3778448 J3781745 J3789378 J3797362 J3807705 J3825388 J3834886 J3849209 J3824979 J3759915 J3770490 J3778449 J3781746 J3789380 J3797363 J3807706 J3825389 J3834887 J3849210 J3826862 J3759916 J3770491 J3778450 J3781747 J3791600 J3797364 J3807707 J3825390 J3834888 J3849211 J3829972 J3759917 J3770492 J3778451 J3781748 J3791601 J3797365 J3807725 J3826857 J3834889 J3849212 J3849214 J3759918 J3770495 J3778452 J3781749 J3791602 J3802679 J3807726 J3826858 J3838209 J3849213 J3851759 J3764261 J3770496 J3778453 J3781751 J3791604 J3802680 J3807727 J3826859 J3838210 J3849215 J3851760 J3764262 J3770498 J3778454 J3781753 J3791605 J3802681 J3808872 J3826860 J3838211 J3849216 J3851763 J3764263 J3772663 J3778455 J3781754 J3792505 J3802682 J3808873 J3826861 J3838212 J3851761 J3854229 J3764265 J3772664 J3778456 J3783540 J3792506 J3802683 J3808874 J3827624 J3838213 J3851762 J3854232 J3764266 J3773181 J3778457 J3783541 J3792507 J3802684 J3810092 J3827625 J3838214 J3851764 J3854233 J3764267 J3773182 J3778458 J3783542 J3792508 J3802685 J3814221 J3827626 J3838215 J3851765 J3854234 J3764268 J3773183 J3778459 J3783543 J3794554 J3802686 J3814222 J3827627 J3838216 J3854226 J3854238 J3764269 J3773185 J3778460 J3783544 J3794555 J3802687 J3814223 J3829973 J3838217 J3854227 J3764270 J3773186 J3778462 J3783546 J3794556 J3802688 J3814225 J3829974 J3842046 J3854228 J3764271 J3773187 J3778463 J3786138 J3794557 J3802689 J3816053 J3829975 J3842047 J3854230 J3767072 J3775026 J3778464 J3786141 J3794558 J3802690 J3816054 J3829976 J3842051 J3854231 J3767073 J3775027 J3778465 J3786142 J3794559 J3802692 J3819261 J3829977 J3842052 J3854236 J3767074 J3775028 J3778466 J3786144 J3794560 J3802693 J3823499 J3829978 J3842054 J3854239 J3767075 J3775030 J3778468 J3786146 J3794561 J3804116 J3823500 J3829981 J3842056 J3858654 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Lot Numbers: J3753942 J3772643 J3787583 J3795048 J3801876 J3807745 J3818106 J3830003 J3837288 J3847278 J3854453 J3754912 J3772645 J3787585 J3795049 J3802715 J3807746 J3823510 J3830004 J3837289 J3847279 J3854454 J3754913 J3772646 J3787590 J3795051 J3802716 J3807747 J3823511 J3830009 J3837290 J3847280 J3854455 J3754915 J3773130 J3787591 J3795052 J3802717 J3807748 J3823512 J3830010 J3837291 J3849157 J3854456 J3754922 J3773131 J3787592 J3795053 J3802718 J3808902 J3823513 J3830653 J3838237 J3849158 J3854460 J3758428 J3773132 J3789444 J3795055 J3802719 J3810111 J3823514 J3830656 J3838238 J3849159 J3857379 J3758430 J3773133 J3789446 J3795059 J3802720 J3810112 J3823544 J3830657 J3838239 J3849161 J3857380 J3758447 J3773134 J3789447 J3795060 J3802721 J3810113 J3823545 J3830658 J3838240 J3849162 J3857384 J3758453 J3773135 J3789449 J3795061 J3802722 J3810114 J3823546 J3830659 J3838241 J3849163 J3857385 J3758458 J3773136 J3789451 J3795062 J3802723 J3810116 J3823547 J3830660 J3838242 J3849164 J3857387 J3759844 J3773138 J3789452 J3797524 J3802761 J3810117 J3823548 J3830661 J3842177 J3849166 J3857411 J3759849 J3774939 J3789453 J3797525 J3802762 J3810118 J3823806 J3830662 J3842178 J3849167 J3857413 J3759850 J3774940 J3789454 J3797526 J3802763
J3810119 J3823807 J3830663 J3842180 J3850670 J3857414 J3759853 J3774941 J3789455 J3797527 J3802764 J3810120 J3823818 J3830664 J3842186 J3850671 J3858762 J3759854 J3774942 J3789456 J3797528 J3802765 J3810121 J3823819 J3833253 J3842190 J3850672 J3754918 J3759855 J3774943 J3789459 J3797529 J3802766 J3810156 J3825021 J3833254 J3842191 J3850673 J3758427 J3764278 J3774944 J3792563 J3797530 J3802768 J3810157 J3825022 J3833255 J3842192 J3850674 J3759843 J3764279 J3774945 J3792565 J3797531 J3802769 J3810158 J3825023 J3833256 J3842193 J3850676 J3759852 J3764280 J3774946 J3792566 J3797532 J3802770 J3812149 J3825024 J3833257 J3844480 J3850677 J3768942 J3764281 J3774947 J3792567 J3797533 J3803305 J3812150 J3825025 J3833258 J3844485 J3850678 J3786228 J3764282 J3774948 J3792568 J3799071 J3803306 J3812151 J3825026 J3833259 J3844486 J3851803 J3789443 J3764283 J3774949 J3792571 J3799072 J3803307 J3812152 J3825027 J3834927 J3844487 J3851804 J3789450 J3765178 J3774950 J3792572 J3799073 J3803308 J3812153 J3825028 J3834928 J3844490 J3851805 J3792564 J3768935 J3774952 J3792600 J3799075 J3803309 J3812154 J3825029 J3834929 J3844491 J3851807 J3792570 J3768939 J3778365 J3792602 J3799076 J3803310 J3812155 J3825030 J3834930 J3844493 J3851809 J3794982 J3768943 J3778366 J3792603 J3799077 J3803311 J3812156 J3825031 J3834931 J3844494 J3851810 J3794984 J3768954 J3778367 J3792604 J3799078 J3803312 J3812164 J3825032 J3834932 J3844495 J3851811 J3794990 J3769323 J3779239 J3792605 J3799079 J3803313 J3812165 J3825033 J3834933 J3844497 J3851812 J3795054 J3769324 J3779240 J3792606 J3799080 J3803314 J3814226 J3825401 J3834934 J3844498 J3851813 J3795056 J3769325 J3779241 J3792607 J3799081 J3803315 J3814227 J3825402 J3834935 J3844502 J3851820 J3795057 J3769326 J3781691 J3792608 J3801305 J3804350 J3814228 J3825403 J3834951 J3844504 J3851821 J3795058 J3769327 J3781692 J3792609 J3801306 J3804351 J3815898 J3825404 J3834952 J3844505 J3851822 J3801308 J3769328 J3781693 J3792610 J3801307 J3804352 J3815899 J3825405 J3834953 J3844506 J3851823 J3801873 J3769347 J3781695 J3794976 J3801309 J3804354 J3815900 J3825406 J3834954 J3844507 J3851824 J3826884 J3769348 J3781696 J3794977 J3801311 J3804355 J3815901 J3825407 J3834955 J3844510 J3851825 J3827669 J3769350 J3781697 J3794978 J3801312 J3804356 J3815902 J3825408 J3834956 J3844511 J3854373 J3829998 J3769351 J3781698 J3794979 J3801313 J3806227 J3816081 J3825409 J3834957 J3847251 J3854374 J3830000 J3769352 J3781700 J3794980 J3801314 J3806228 J3816083 J3825410 J3837131 J3847252 J3854375 J3842179 J3769353 J3781702 J3794983 J3801315 J3806229 J3816085 J3825411 J3837132 J3847253 J3854376 J3844482 J3769354 J3781703 J3794985 J3801316 J3806230 J3816086 J3826885 J3837133 J3847254 J3854377 J3847255 J3769355 J3786219 J3794986 J3801317 J3806231 J3816087 J3826886 J3837134 J3847256 J3854378 J3847281 J3770460 J3786220 J3794987 J3801318 J3806232 J3816088 J3826887 J3837135 J3847257 J3854379 J3849160 J3770461 J3786221 J3794988 J3801319 J3806236 J3816089 J3826888 J3837136 J3847258 J3854380 J3850675 J3770463 J3786222 J3794989 J3801320 J3806237 J3816091 J3826889 J3837144 J3847259 J3854381 J3851808 J3770464 J3786223 J3794991 J3801867 J3806240 J3818092 J3827665 J3837145 J3847260 J3854382 J3854457 J3770466 J3786224 J3794992 J3801868 J3806241 J3818095 J3827666 J3837146 J3847261 J3854383 J3857382 J3770467 J3786225 J3794993 J3801869 J3807739 J3818096 J3827667 J3837147 J3847262 J3854384 J3857386 J3770468 J3786226 J3794994 J3801870 J3807741 J3818098 J3829997 J3837284 J3847263 J3854446 J3857412 J3772639 J3786232 J3794995 J3801871 J3807742 J3818100 J3829999 J3837285 J3847264
J3854447 J3857417 J3772640 J3786233 J3795045 J3801872 J3807743 J3818103 J3830001 J3837286 J3847265 J3854448 J3772642 J3787581 J3795046 J3801875 J3807744 J3818104 J3830002 J3837287 J3847266 J3854452 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Lot Numbers: J3751062 J3767087 J3778378 J3788090 J3797405 J3802666 J3806206 J3816068 J3829983 J3837124 J3854180 J3753967 J3767088 J3778379 J3788092 J3798231 J3802667 J3806208 J3816070 J3829984 J3837125 J3854181 J3754895 J3767089 J3778380 J3788094 J3798232 J3802668 J3808171 J3818125 J3829985 J3840010 J3854182 J3754899 J3767090 J3778382 J3788096 J3798233 J3802669 J3808172 J3818127 J3829986 J3842101 J3854183 J3757615 J3767092 J3778383 J3788097 J3798234 J3802670 J3808173 J3818130 J3829987 J3842104 J3856888 J3757617 J3767093 J3778384 J3788104 J3798235 J3802671 J3808174 J3818132 J3829988 J3842105 J3858616 J3757619 J3767094 J3778385 J3788105 J3798236 J3802672 J3808175 J3818134 J3830612 J3844344 J3788099 J3757620 J3767095 J3779279 J3788106 J3798237 J3802673 J3808913 J3818135 J3830613 J3844345 J3788100 J3757644 J3767823 J3779280 J3789085 J3798238 J3802746 J3808914 J3818136 J3830614 J3847170 J3788102 J3757645 J3767825 J3779281 J3789086 J3798255 J3802748 J3810074 J3818137 J3830643 J3847171 J3789097 J3757648 J3767826 J3779282 J3789087 J3798256 J3802749 J3810075 J3818139 J3830644 J3847173 J3797391 J3757649 J3770449 J3779283 J3789088 J3798257 J3802750 J3812157 J3818140 J3830645 J3847174 J3797402 J3757651 J3770454 J3779284 J3789089 J3798258 J3802751 J3812158 J3819254 J3830647 J3847175 J3797403 J3757653 J3772614 J3781723 J3789092 J3798260 J3802752 J3812159 J3819255 J3830648 J3847176 J3798259 J3758481 J3772617 J3781724 J3789094 J3798261 J3802753 J3812160 J3819256 J3830649 J3847177 J3798262 J3758483 J3772618 J3781726 J3789095 J3798264 J3802754 J3812161 J3823526 J3830650 J3847178 J3798265 J3758486 J3773071 J3781728 J3789096 J3798266 J3802755 J3814216 J3823527 J3830651 J3847179 J3825011 J3759831 J3773073 J3781731 J3789098 J3801353 J3802756 J3814217 J3823528 J3833239 J3848962 J3827653 J3759832 J3773075 J3781732 J3791607 J3801356 J3802757 J3814218 J3823529 J3834911 J3848963 J3829989 J3759833 J3773076 J3781733 J3797386 J3802628 J3802758 J3815879 J3823530 J3834913 J3848965 J3830615 J3759834 J3773077 J3781734 J3797387 J3802629 J3802759 J3815880 J3823537 J3834914 J3848966 J3834919 J3759835 J3773078 J3786082 J3797388 J3802630 J3802760 J3815881 J3823538 J3834915 J3848967 J3840013 J3762525 J3773079 J3786083 J3797389 J3802631 J3804055 J3815882 J3825010 J3834916 J3848968 J3844343 J3762526 J3773080 J3786088 J3797390 J3802632 J3804056 J3815883 J3825012 J3834917 J3848971 J3847172 J3762527 J3773202 J3786089 J3797392 J3802635 J3804057 J3815884 J3825013 J3834920 J3848972 J3848961 J3762528 J3773203 J3786090 J3797393 J3802640 J3804058 J3815885 J3825014 J3834921 J3848974 J3848964 J3762529 J3773204 J3786091 J3797394 J3802641 J3804059 J3815886 J3825015 J3834922 J3848975 J3848969 J3762530 J3773205 J3786092 J3797395 J3802658 J3804060 J3815887 J3827642 J3834923 J3848976 J3848970 J3762531 J3777910 J3786097 J3797396 J3802660 J3804061 J3815888 J3827643 J3834925 J3854170 J3854174 J3762532 J3777911 J3786098 J3797397 J3802661 J3804062 J3815979 J3827644 J3837119 J3854173 J3856885 J3762533 J3777912 J3786099 J3797398 J3802662 J3806202 J3816064 J3827646 J3837120 J3854175 J3762545 J3777913 J3786100 J3797400 J3802663 J3806203 J3816065 J3827647 J3837121 J3854176 J3762546 J3778375 J3788087 J3797401 J3802664 J3806204 J3816066 J3827651 J3837122 J3854178 J3767086 J3778376 J3788088 J3797404 J3802665 J3806205 J3816067 J3829982 J3837123 J3854179 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Lot Numbers: J3750403 J3773088 J3778418 J3791636 J3797457 J3804235 J3818060 J3834948 J3844443 J3849104 J3854400 J3750405 J3773090 J3778419 J3791637 J3797458 J3804236 J3818061 J3834949 J3844445 J3849105 J3854402 J3750406 J3773091 J3778420 J3791638 J3797459 J3804237 J3819276 J3834950 J3844446 J3849106 J3775006 J3753986 J3773092 J3778421 J3791639 J3797460 J3806209 J3823519 J3837152 J3844448 J3849107 J3786161 J3753988 J3773093 J3778423 J3791640 J3797462 J3808154 J3823520 J3837154 J3844449 J3849108 J3794961 J3753991 J3773095 J3778424 J3791641 J3801297 J3808155 J3823521 J3840053 J3844450 J3849109 J3824989 J3753992 J3773096 J3778425 J3792555 J3801298 J3808156 J3824990 J3840055 J3844451 J3849111 J3826871 J3757601 J3774959 J3778426 J3792556 J3801299 J3808157 J3824991 J3840057 J3844452 J3849112 J3827628 J3762580 J3774961 J3778427 J3792557 J3801300 J3808158 J3824992 J3840060 J3844454 J3849114 J3847244 J3762581 J3774962 J3778431 J3792558 J3801301 J3808159 J3826866 J3840061 J3844456 J3851779 J3851785 J3762582 J3774963 J3778432 J3794955 J3801303 J3808858 J3826867 J3840062 J3844457 J3851780 J3854395 J3768930 J3775000 J3779302 J3794957 J3801304 J3808917 J3826868 J3840063 J3844458 J3851781 J3854398 J3769360 J3775001 J3781737 J3794958 J3802702 J3808918 J3826869 J3842134 J3844459 J3851782 J3854401 J3769361 J3775002 J3781739 J3794959 J3802704 J3810200 J3826870 J3844377 J3844461 J3851783 J3857391 J3769362 J3775004 J3785388 J3794960 J3802706 J3810201 J3827629 J3844378 J3846039 J3851784 J3857395 J3769368 J3775007 J3786157 J3794962 J3802707 J3814234 J3827630 J3844379 J3846041 J3851786 J3769369 J3775008 J3786159 J3797445 J3802708 J3814235 J3827631 J3844380 J3847243 J3851787 J3769370 J3775009 J3786160 J3797447 J3802709 J3814236 J3827632 J3844381 J3847245 J3851788 J3772621 J3775010 J3786166 J3797448 J3802710 J3814237 J3827633 J3844382 J3847246 J3851789 J3772623 J3775011 J3786167 J3797450 J3802711 J3816048 J3830011 J3844385 J3847247 J3851791 J3772624 J3775012 J3789391 J3797452 J3802712 J3816049 J3830013 J3844386 J3847248 J3854394 J3772625 J3775013 J3789394 J3797454 J3802713 J3816050 J3834945 J3844440 J3847249 J3854396 J3773084 J3775014 J3791634 J3797455 J3804233 J3816051 J3834946 J3844441 J3847250 J3854397 J3773087 J3775015 J3791635 J3797456 J3804234 J3818059 J3834947 J3844442 J3849103 J3854399 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Lot Numbers: J3754024 J3764354 J3773226 J3779321 J3783574 J3792595 J3806196 J3806217 J3816092 J3827527 J3844410 J3754027 J3764356 J3773227 J3781794 J3783575 J3792598 J3806197 J3806218 J3816093 J3830017 J3844412 J3754028 J3767830 J3773228 J3781795 J3785408 J3792599 J3806198 J3806219 J3816094 J3830018 J3844413 J3754031 J3767831 J3773229 J3781797 J3786192 J3797520 J3806199 J3806220 J3816095 J3830020 J3844414 J3754934 J3769386 J3773233 J3781801 J3786194 J3797521 J3806200 J3806221 J3816096 J3830021 J3858764 J3759864 J3769387 J3775078 J3781802 J3786195 J3797522 J3806201 J3806222 J3819272 J3830703 J3754032 J3759865 J3769388 J3775079 J3781803 J3786196 J3806189 J3806210 J3806223 J3819273 J3830704 J3773232 J3759867 J3772692 J3775080 J3781804 J3786197 J3806190 J3806211 J3806224 J3823959 J3838247 J3775077 J3759869 J3772693 J3775081 J3783568 J3786198 J3806191 J3806212 J3806225 J3825416 J3842147 J3789408 J3759870 J3772695 J3775082 J3783569 J3786199 J3806192 J3806213 J3807710 J3825417 J3842149 J3791647 J3764351 J3772698 J3775084 J3783570 J3789407 J3806193 J3806214 J3807711 J3827524 J3842150 J3791649 J3764352 J3773223 J3775085 J3783572 J3791643 J3806194 J3806215 J3808163 J3827525
J3842152 J3764353 J3773224 J3779320 J3783573 J3791648 J3806195 J3806216 J3808889 J3827526 J3842153 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Lot Numbers: J3753241 J3759881 J3764316 J3775058 J3778408 J3792585 J3821117 J3826846 J3844348 J3847198 J3849075 J3753243 J3759882 J3764320 J3775059 J3783495 J3808189 J3821118 J3826847 J3844349 J3847199 J3851766 J3758459 J3759884 J3764321 J3775060 J3783496 J3808910 J3823491 J3833217 J3844350 J3847201 J3851767 J3758462 J3762565 J3764322 J3775061 J3783497 J3812175 J3823492 J3833218 J3844352 J3847203 J3847200 J3758463 J3762566 J3764324 J3775062 J3783498 J3815863 J3826841 J3833219 J3844353 J3847204 J3847202 J3758464 J3762567 J3772651 J3775064 J3789976 J3815866 J3826842 J3833220 J3844354 J3849070 J3849069 J3758465 J3762568 J3772652 J3775065 J3789977 J3815868 J3826843 J3833221 J3844355 J3849072 J3758466 J3762569 J3775056 J3778406 J3789978 J3821113 J3826844 J3844346 J3844356 J3849073 J3758467 J3762570 J3775057 J3778407 J3792584 J3821116 J3826845 J3844347 J3844357 J3849074 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Lot Numbers: J3754929 J3769336 J3773156 J3786212 J3789422 J3806235 J3821110 J3825050 J3834854 J3844300 J3847169 J3754930 J3770507 J3773158 J3786213 J3801289 J3808160 J3821143 J3830024 J3834855 J3844301 J3854210 J3754931 J3770508 J3778482 J3787577 J3801290 J3808911 J3821144 J3830026 J3844294 J3844302 J3854214 J3759782 J3770509 J3778483 J3787578 J3801291 J3808912 J3823822 J3830027 J3844295 J3844304 J3786214 J3759785 J3770510 J3783559 J3789418 J3803293 J3810189 J3823824 J3834850 J3844296 J3844305 J3789417 J3767780 J3770511 J3785403 J3789419 J3803294 J3810190 J3823825 J3834851 J3844297 J3844306 J3830025 J3769334 J3773153 J3785404 J3789420 J3806233 J3815873 J3825048 J3834852 J3844298 J3847167 J3830029 J3769335 J3773155 J3786211 J3789421 J3806234 J3815874 J3825049 J3834853 J3844299 J3847168 J3854213 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Lot Numbers: J3719231 J3764385 J3773102 J3792591 J3800701 J3801865 J3808880 J3821130 J3829970 J3844286 J3795043 J3753276 J3764386 J3773106 J3792593 J3800702 J3801866 J3810100 J3821131 J3830633 J3844287 J3823506 J3753278 J3764387 J3773107 J3795024 J3800703 J3803328 J3810101 J3821132 J3830634 J3844288 J3827615 J3754886 J3764388 J3778386 J3795025 J3801849 J3803329 J3815875 J3823504 J3834857 J3844289 J3830632 J3754889 J3764389 J3778387 J3795026 J3801850 J3803330 J3816045 J3823505 J3834858 J3844290 J3849020 J3754892 J3764390 J3778388 J3795027 J3801851 J3803331 J3816046 J3824961 J3834859 J3844291 J3851757 J3758406 J3767101 J3778389 J3795028 J3801852 J3803332 J3816047 J3824962 J3834860 J3844292 J3851758 J3758409 J3767102 J3778390 J3795029 J3801853 J3803333 J3818048 J3824963 J3838125 J3849015 J3854202 J3758411 J3767103 J3778393 J3795030 J3801854 J3807716 J3818049 J3824964 J3838128 J3849017 J3854205 J3758412 J3767104 J3778394 J3795032 J3801855 J3807717 J3818050 J3824965 J3838130 J3849018 J3758415 J3767105 J3778415 J3795033 J3801856 J3807718 J3818051 J3824966 J3838134 J3849021 J3764292 J3767819 J3783505 J3795034 J3801857 J3807719 J3818052 J3827613 J3838136 J3849022 J3764293 J3769383 J3783507 J3795036 J3801858 J3808176 J3818053 J3827614 J3838138 J3849023 J3764294 J3769384 J3789359 J3795037 J3801859 J3808177 J3821109 J3827616 J3842074 J3849024 J3764295 J3769385 J3789360 J3795039 J3801860 J3808179 J3821125 J3827618 J3842075 J3851756 J3764296 J3772635 J3789361 J3795041 J3801861 J3808180 J3821126 J3827619 J3842076 J3754890 J3764382 J3773099 J3789362 J3795042 J3801862 J3808181 J3821127 J3829967 J3842078 J3792590 J3764383 J3773100 J3789363 J3800699 J3801863 J3808182 J3821128 J3829968 J3842079 J3792592 J3764384 J3773101 J3792589 J3800700 J3801864 J3808183 J3821129 J3829969 J3842081 J3795038 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Lot Numbers: J3755763 J3760355 J3770505 J3786064 J3794942 J3808167 J3823803 J3830636 J3838285 J3847190 J3851827 J3755767 J3762584 J3772680 J3786066 J3794943 J3808168 J3823804 J3833276 J3838287 J3847191 J3851828 J3759760 J3762585 J3772681 J3786068 J3794944 J3808169 J3823805 J3833277 J3838288 J3847192 J3854221 J3759765 J3762586 J3773188 J3786071 J3794945 J3808170 J3824944 J3833278 J3838289 J3847193 J3854223 J3759766 J3762587 J3773189 J3786073 J3794946 J3808876 J3824945 J3833279 J3842091 J3847194 J3856916 J3759767 J3762589 J3773190 J3786074 J3794947 J3810095 J3824946 J3833280 J3842092 J3847195 J3759930 J3759769 J3764273 J3773191 J3789076 J3797406 J3810096 J3824947 J3834960 J3842094 J3847196 J3763801 J3759770 J3764274 J3773192 J3789077 J3797407 J3810097 J3824948 J3834961 J3844318 J3847197 J3764394 J3759771 J3764391 J3773193 J3789078 J3797408 J3810098 J3824949 J3834962 J3844319 J3849032 J3791629 J3759772 J3764392 J3773194 J3789082 J3797410 J3810099 J3824950 J3834963 J3844320 J3849035 J3794936 J3759773 J3764393 J3775041 J3789083 J3797411 J3812166 J3826834 J3834964 J3844322 J3849036 J3801282 J3759774 J3764395 J3775042 J3791627 J3797412 J3812167 J3826835 J3834965 J3844323 J3849038 J3826836 J3759921 J3764396 J3775043 J3791628 J3801281 J3812168 J3826837 J3834967 J3844324 J3849040 J3829954 J3759922 J3764397 J3775044 J3791630 J3801283 J3812169 J3826838 J3834968 J3844325 J3849041 J3849037 J3759923 J3764398 J3775045 J3791631 J3801284 J3812170 J3826839 J3834969 J3844326 J3849042 J3850658 J3759924 J3764399 J3775046 J3791632 J3801285 J3816056 J3826840 J3837299 J3844327 J3849043 J3854222 J3759926 J3764401 J3778472 J3791633 J3801286 J3819258 J3829945 J3837300 J3844328 J3850205 J3856917 J3759927 J3764402 J3778473 J3792550 J3801287 J3819259 J3829946 J3837301 J3844329 J3850652 J3856918 J3759928 J3764403 J3778474 J3792551 J3807374 J3819260 J3829947 J3837302 J3844330 J3850653 J3856919 J3759929 J3764404 J3778475 J3792552 J3807375 J3821120 J3829948 J3837303 J3844331 J3850654 J3760348 J3768923 J3778476 J3794935 J3807376 J3821121 J3829949 J3837304 J3844332 J3850655 J3760349 J3769310 J3778477 J3794937 J3807377 J3821122 J3829952 J3838277 J3844333 J3850656 J3760351 J3770500 J3779298 J3794938 J3807378 J3821123 J3829953 J3838278 J3844334 J3850657 J3760352 J3770501 J3783521 J3794939 J3807379 J3821124 J3829961 J3838282 J3844335 J3850659 J3760353 J3770503 J3783523 J3794940 J3808165 J3823503 J3829962 J3838283 J3844336 J3850660 J3760354 J3770504 J3783525 J3794941 J3808166 J3823802 J3829963 J3838284 J3844337 J3851826 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Lot Numbers: J3750469 J3769344 J3779271 J3789433 J3799365 J3807364 J3810108 J3823534 J3834941 J3849181 J3858705 J3750471 J3769345 J3779273 J3789435 J3799367 J3807365 J3810109 J3823535 J3834942 J3849182 J3858707 J3753980 J3769346 J3779274 J3789436 J3799368 J3807366 J3810110 J3823536 J3834943 J3849185 J3858708 J3754906 J3770478 J3781761 J3789437 J3801326 J3807367 J3810151 J3823816 J3834944 J3850679 J3786182 J3757642 J3770479 J3781762 J3789439 J3801327 J3807368 J3810152 J3823817 J3837137 J3850680 J3787574 J3757643 J3770483 J3781763 J3789440 J3801329 J3807369 J3810153 J3825034 J3837139 J3850681 J3789431 J3758433 J3770484 J3781764 J3789441 J3801330 J3807371 J3810154 J3825035 J3837140 J3850682 J3792577 J3758439 J3773120 J3783490 J3792573 J3801331 J3807372 J3810155 J3825036 J3837141 J3850683 J3795015 J3758445 J3773121 J3783491 J3792579 J3801332 J3807732 J3814229 J3825037 J3842154 J3851814 J3799366 J3764285 J3773123 J3783492 J3792580 J3801333 J3807733 J3814230 J3825038 J3842155 J3851815 J3802724 J3764286 J3773124 J3783493 J3792581 J3801334 J3807734 J3814231 J3825039 J3842156 J3851816 J3827675 J3764289 J3773125 J3783494 J3792582 J3801335 J3807735 J3814232 J3825040 J3842157 J3851817 J3830005 J3764303 J3774972 J3785399 J3792583 J3801336 J3807736 J3814233 J3825412 J3842161 J3851818 J3830669 J3764304 J3774974 J3786172 J3795001 J3801337 J3807737 J3815903 J3825413 J3844465 J3854413 J3849179 J3764306 J3774975 J3786173 J3795004 J3801338 J3807738 J3815904 J3825414 J3844466 J3854414 J3849184 J3764307 J3774976 J3786174 J3795006 J3801339 J3807749 J3815905 J3825415 J3844467 J3854416 J3849186 J3764308 J3774977 J3786175 J3795008 J3802725 J3807750 J3816075 J3826890 J3844472 J3854417 J3854387 J3764312 J3774978 J3786179 J3795009 J3802726 J3807751 J3816076 J3826892 J3844473 J3854419 J3854418 J3764340 J3774979 J3786181 J3795010 J3802727 J3807752 J3816077 J3826893 J3844475 J3854421 J3854428 J3764341 J3774980 J3786183 J3795011 J3802728 J3807753 J3816078 J3826894 J3844476 J3854422 J3854429 J3764342 J3774981 J3786184 J3795012 J3802729 J3807754 J3816079 J3826895 J3844477 J3854423 J3854433 J3764343 J3774982 J3786186 J3795014 J3802730 J3807755 J3816080 J3827676 J3844478 J3854424 J3854438 J3764344 J3778368 J3786188 J3795016 J3802731 J3807756 J3818065 J3827677 J3844479 J3854430 J3854440 J3764345 J3778372 J3787568 J3795017 J3802732 J3807757 J3818066 J3830006 J3847267 J3854431 J3854479 J3764346 J3778374 J3787569 J3795018 J3802733 J3807758 J3818067 J3830007 J3847268 J3854432 J3854480 J3768957 J3778396 J3787570 J3795021 J3802734 J3808893 J3818068 J3830008 J3847269 J3854435 J3854484 J3768960 J3778397 J3787571 J3798275 J3802735 J3808894 J3818069 J3830668 J3847270 J3854436 J3854485 J3769007 J3778398 J3787573 J3798276 J3802736 J3808895 J3818070 J3830670 J3847271 J3854442 J3854487 J3769009 J3778399 J3789423 J3798433 J3802737 J3808896 J3818071 J3830671 J3847272 J3854477 J3857400 J3769010 J3778400 J3789424 J3798434 J3802738 J3808897 J3818072 J3830672 J3847273 J3854478 J3769329 J3778401 J3789425 J3799358 J3803266 J3808898 J3818073 J3830673 J3847274 J3854483 J3769330 J3778402 J3789426 J3799359 J3803267 J3808899 J3818074 J3833260 J3847275 J3854488 J3769332 J3778403 J3789427 J3799360 J3803268 J3808900 J3819270 J3833261 J3847276 J3854490 J3769333 J3778404 J3789428 J3799361 J3804239 J3810104 J3819271 J3833262 J3849174 J3854492 J3769340 J3778405 J3789429 J3799362 J3804240 J3810105 J3821137 J3834938 J3849175 J3854494 J3769341 J3779269 J3789430 J3799363 J3804241 J3810106 J3823531 J3834939 J3849176 J3857401 J3769343 J3779270 J3789432 J3799364 J3806985 J3810107 J3823532 J3834940 J3849178 J3857409 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Lot Numbers: J3747489 J3762544 J3779260 J3786127 J3799052 J3803341 J3810080 J3825400 J3838221 J3847228 J3856903 J3750140 J3764297 J3781709 J3786129 J3799053 J3803342 J3810081 J3826874 J3838222 J3848977 J3753337 J3751054 J3764298 J3781711 J3786130 J3799054 J3803343 J3812140 J3826875 J3838223 J3848978 J3759821 J3753334 J3764299 J3781712 J3786131 J3799055 J3803344 J3812141 J3826876 J3838224 J3848979 J3767794 J3754909 J3764300 J3781714 J3789368 J3799056 J3803345 J3812142 J3826877 J3838232 J3848980 J3769322 J3759813 J3764301 J3781715 J3794829 J3799057 J3803346 J3812143 J3826878 J3838233 J3848994 J3786118 J3759817 J3767795 J3781716 J3797366 J3799058 J3807360 J3812144 J3826879 J3840014 J3848995 J3789366 J3759818 J3767796 J3781717 J3797367 J3799060 J3807361 J3812145 J3827636 J3840015 J3848996 J3798223 J3759819 J3767798 J3781718 J3797369 J3799061 J3807362 J3812146 J3827637 J3840016 J3848997 J3798252 J3759824 J3770457 J3781719 J3797370 J3800670 J3807363 J3812147 J3827638 J3840017 J3848998 J3799059 J3759825 J3770459 J3781720 J3797371 J3800671 J3807720 J3812148 J3829991 J3842121 J3848999 J3819136 J3759826 J3772683 J3783508 J3797372 J3800672 J3807721 J3815889 J3833241 J3842122 J3849000 J3825394 J3762511 J3772685 J3783509 J3797373 J3800673 J3807722 J3815978 J3833242 J3842123 J3849002 J3849001 J3762512 J3772686 J3783510 J3797374 J3800682 J3807723 J3816062 J3833246 J3842126 J3849003 J3849091 J3762513 J3773195 J3783511 J3797375 J3800684 J3807724 J3819137 J3833247 J3842127 J3849088 J3849092 J3762515 J3773197 J3783512 J3797376 J3800685 J3807759 J3819262 J3833248 J3842129 J3849089 J3849097 J3762516 J3773198 J3783513 J3797377 J3800687 J3807760 J3819263 J3833249 J3842131 J3849090 J3850665 J3762517 J3773199 J3783514 J3797378 J3800688 J3807761 J3819264 J3833250 J3842546 J3849093 J3851750 J3762519 J3773200 J3783515 J3797379 J3800689 J3807762 J3819265 J3834890 J3844366 J3849094 J3854187 J3762520 J3773201 J3783516 J3798225 J3800690 J3807763 J3819266 J3834891 J3844367 J3849095 J3854191 J3762521 J3774936 J3785378 J3798226 J3800691 J3807764 J3819268 J3834892 J3844368 J3849096 J3856899 J3762523 J3774937 J3785381 J3798227 J3800692 J3807765 J3819269 J3834893 J3844369 J3850661 J3762524 J3779248 J3785382 J3798228 J3800693 J3807766 J3821115 J3834894 J3844372 J3850662 J3762534 J3779249 J3786114 J3798229 J3800694 J3807767 J3823540 J3834895 J3844373 J3850663 J3762535 J3779250 J3786115 J3798230 J3800695 J3808881 J3823541 J3834896 J3847217 J3850666 J3762536 J3779251 J3786116 J3798245 J3800696 J3808882 J3825391 J3834897 J3847219 J3850667 J3762537 J3779252 J3786117 J3798246 J3803334 J3808883 J3825392 J3834898 J3847220 J3851748 J3762538 J3779253 J3786119 J3798247 J3803335 J3808884 J3825393 J3834899 J3847221 J3851749 J3762539 J3779254 J3786120 J3798248 J3803336 J3808885 J3825395 J3834900 J3847222 J3854186 J3762540 J3779255 J3786123 J3798249 J3803337 J3808886 J3825396 J3834901 J3847224 J3854188 J3762541 J3779256 J3786124 J3798250 J3803338 J3810077 J3825397 J3838218 J3847225 J3854194 J3762542 J3779257 J3786125 J3798253 J3803339 J3810078 J3825398 J3838219 J3847226 J3854195 J3762543 J3779258 J3786126 J3798254 J3803340 J3810079 J3825399 J3838220 J3847227 J3856901 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Lot Numbers: J3753304 J3769365 J3774953 J3792541 J3803319 J3815894 J3823810 J3833270 J3844415 J3847239 J3857398 J3754010 J3770486 J3774954 J3792542 J3803320 J3815896 J3823811 J3833272 J3844416 J3847240 J3757665 J3754011 J3770487 J3774955 J3792544 J3803321 J3815897 J3823812 J3837155 J3844418 J3847241 J3757668 J3754013 J3770488 J3774956 J3797463 J3807780 J3816099 J3823813 J3837156 J3844419 J3847242 J3774958 J3754926 J3771231 J3774957 J3797465 J3807781 J3816100 J3823814 J3837157 J3844420 J3849122 J3789406 J3754927 J3771233 J3778433 J3797466 J3807782 J3816101 J3824997 J3837158 J3844421 J3849124 J3823809 J3757660 J3771234 J3778434 J3797467 J3807784 J3816104 J3824998 J3837159 J3844422 J3849125 J3825000 J3757663 J3771235 J3778437 J3797469 J3808153 J3816105 J3824999 J3838254 J3844423 J3849126 J3826896 J3757666 J3772655 J3778438 J3799062 J3808904 J3816107 J3826903 J3838255 J3844424 J3849127 J3827683 J3759891 J3772657 J3779307 J3799063 J3808905 J3816108 J3826915 J3838256 J3844425 J3849128 J3830015 J3759896 J3772658 J3783535 J3799065 J3808906 J3816109 J3826920 J3838257 J3844426 J3849130 J3833271 J3759897 J3773167
J3786153 J3799066 J3810192 J3816111 J3826925 J3838258 J3844427 J3849131 J3851798 J3759899 J3773168 J3786155 J3799067 J3810193 J3819277 J3827682 J3838259 J3847229 J3849132 J3759902 J3773170 J3786156 J3799068 J3810194 J3819278 J3827684 J3838261 J3847230 J3851794 J3759905 J3773171 J3787393 J3802620 J3810195 J3819279 J3830014 J3840019 J3847231 J3851795 J3759906 J3773172 J3789401 J3802621 J3812171 J3821133 J3830016 J3840021 J3847232 J3851796 J3764371 J3773173 J3789402 J3802622 J3812172 J3821134 J3830677 J3840022 J3847233 J3851797 J3764372 J3773174 J3789403 J3802623 J3814238 J3821135 J3830678 J3840024 J3847234 J3851799 J3764373 J3773175 J3789404 J3802624 J3814239 J3821136 J3830679 J3840025 J3847235 J3851800 J3764374 J3773176 J3789405 J3802626 J3814240 J3823523 J3830680 J3840026 J3847236 J3851801 J3764377 J3773177 J3792538 J3802627 J3815892 J3823524 J3830681 J3840028 J3847237 J3854403 J3764380 J3773178 J3792540 J3803318 J3815893 J3823808 J3833269 J3840029 J3847238 J3854407 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Lot Numbers: J3749445 J3762556 J3773159 J3778502 J3789412 J3797503 J3808878 J3821111 J3826940 J3847288 J3767818 J3749449 J3762557 J3773161 J3778504 J3789414 J3797504 J3810057 J3823551 J3826941 J3849206 J3825045 J3753262 J3762558 J3773163 J3778505 J3789415 J3797505 J3810058 J3823552 J3826942 J3849207 J3851774 J3753265 J3764357 J3773164 J3778506 J3789416 J3797506 J3810059 J3823553 J3826943 J3849208 J3753268 J3764359 J3773165 J3779323 J3794574 J3797508 J3810060 J3823554 J3826944 J3851768 J3762547 J3764360 J3775089 J3779324 J3794575 J3797509 J3810061 J3823555 J3826945 J3851769 J3762548 J3764361 J3775090 J3783549 J3794576 J3797510 J3812173 J3823820 J3842137 J3851770 J3762549 J3764362 J3778493 J3783552 J3794577 J3797511 J3815871 J3823821 J3842138 J3851771 J3762550 J3764363 J3778494 J3783556 J3794578 J3797512 J3815872 J3825042 J3847282 J3851773 J3762551 J3764364 J3778495 J3783557 J3797497 J3807712 J3816097 J3825043 J3847284 J3854307 J3762552 J3764367 J3778496 J3783558 J3797498 J3807713 J3816098 J3825044 J3847285 J3854310 J3762554 J3764368 J3778497 J3789410 J3797500 J3807714 J3819274 J3825046 J3847286 J3856925 J3762555 J3767817 J3778500 J3789411 J3797501 J3807715 J3819275 J3825047 J3847287 J3856928 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5 Lot Numbers: J3758468 J3762573 J3764334 J3774992 J3792588 J3816041 J3827458 J3833224 J3847213 J3849086 J3847216 J3758471 J3762574 J3764337 J3783500 J3808190 J3816042 J3827611 J3833225 J3847214 J3854302 J3849082 J3758472 J3762576 J3764339 J3783501 J3808909 J3816043 J3829955 J3847205 J3847215 J3854303 J3758473 J3764328 J3769359 J3783502 J3812174 J3816044 J3829956 J3847206 J3849079 J3783504 J3758474 J3764330 J3772653 J3783503 J3815869 J3821112 J3829957 J3847207 J3849080 J3789980 J3758475 J3764331 J3772654 J3789979 J3815870 J3825379 J3829958 J3847210 J3849081 J3789982 J3758476 J3764332 J3774990 J3789984 J3816039 J3825380 J3833222 J3847211 J3849083 J3847208 J3762571 J3764333 J3774991 J3789985 J3816040 J3825381 J3833223 J3847212 J3849084 J3847209 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact | Customer Service 574-371-3071 |
Manufacturer Reason for Recall | packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery. |
FDA Determined Cause 2 | Process change control |
Action | On 1/4/2017 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and hospital Risk Managers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributor responsibilities include:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks (January 20, 2017). a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com. Be sure to specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Mark the outside of the returns box(es) clearly with RECALL.
5. Note that any hospitals that received direct shipments of this product from Zimmer Biomet or were consigned products will be sent a copy of the Risk Manager Recall Notice directly. It is important that you review the list of hospitals included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals from which you removed affected product. This form will be used to notify each account. If there are no addit |
Quantity in Commerce | 15,000 |
Distribution | NATIONWIDE US
ARGENTINA
AUSTRALIA
AUSTRIA
BRAZIL
CANADA
CHILE
CHINA
COSTA RICA
ECUADOR
GREECE
INDIA
ITALY
JAPAN
KOREA, THE REP OF (SOUTH)
MALAYSIA
MEXICO
NETHERLANDS
PANAMA
POLAND
SINGAPORE
THAILAND |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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