FDAFDA · Food and drugs·Recall number Z-1115-2017
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
Published February 8, 2017 · Recall initiated: January 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Biomet, Inc.
- Distributor
- 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
- Lot
- 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 J376931
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.