FDAFDA · Food and drugs·Recall number Z-0699-2020

Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, NATRELLE Style 68LP-200 Saline Round Low 10888628000544, NATRELLE Style 68LP-225 Saline Round Low 10888628000551, NATRELLE Style 68LP-250 Saline Round Low 10888628000568, NATRELLE Style 68LP-275 Saline Round Low 10888628000575, NATRELLE Style 68LP-300 Saline Round Low 10888628000582, NATRELLE Style 68LP-325 Saline Round Low 10888628000599, NATRELLE Style 68LP-350 Saline Round Low 10888628000605, NATRELLE Style 68LP-400 Saline Round Low 10888628000612, NATRELLE Style 68LP-420 Saline Round Low 10888628000629, NATRELLE Style 68LP-440 Saline Round Low 10888628000636, NATRELLE Style 68LP-480 Saline Round Low 10888628000643, NATRELLE Style 68LP-525 Saline Round Low 10888628000650, NATRELLE Style 68LP-550 Saline Round Low 10888628000667, NATRELLE Style 68LP-600 Saline Round Low 10888628000674, NATRELLE Style 68LP-640 Saline Round Low 10888628000681, NATRELLE Style 68LP-680 Saline Round Low 10888628000698, Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High 10888628000353, NATRELLE Style 68HP-200 Saline Round High 10888628000360, NATRELLE Style 68HP-240 Saline Round High 10888628000377, NATRELLE Style 68HP-280 Saline Round High 10888628000384, NATRELLE Style 68HP-320 Saline Round High 10888628000391, NATRELLE Style 68HP-350 Saline Round High 10888628000407, NATRELLE Style 68HP-400 Saline Round High 10888628000414, NATRELLE Style 68HP-425 Saline Round High 10888628000421, NATRELLE Style 68HP-465 Saline Round High 10888628000438, NATRELLE Style 68HP-500 Saline Round High 10888628000445, NATRELLE Style 68HP-550 Saline Round High 10888628000452, NATRELLE Style 68HP-600 Saline Round High 10888628000469, NATRELLE Style 68HP-650 Saline Round High 10888628000476, NATRELLE Style 68HP-700 Saline Round High 10888628000483, NATRELLE Style 68HP-750 Saline Round High 10888628000490, NATRELLE Style 68HP-800 Saline Round High 10888628000506, Style 68 MP/UDI: NATRELLE Style 68MP-120 Saline Round Mod 10888628000155, NATRELLE Style 68MP-150 Saline Round Mod 10888628000162, NATRELLE Style 68MP-180 Saline Round Mod 10888628000179, NATRELLE Style 68MP-210 Saline Round Mod 10888628000186, NATRELLE Style 68MP-240 Saline Round Mod 10888628000193, NATRELLE Style 68MP-270 Saline Round Mod 10888628000209, NATRELLE Style 68MP-300 Saline Round Mod 10888628000216, NATRELLE Style 68MP-330 Saline Round Mod 10888628000223, NATRELLE Style 68MP-360 Saline Round Mod 10888628000230, NATRELLE Style 68MP-390 Saline Round Mod 10888628000247, NATRELLE Style 68MP-420 Saline Round Mod 10888628000254, NATRELLE Style 68MP-450 Saline Round Mod 10888628000261, NATRELLE Style 68MP-480 Saline Round Mod 10888628000278, NATRELLE Style 68MP-510 Saline Round Mod 10888628000285, NATRELLE Style 68MP-550 Saline Round Mod 10888628000292, NATRELLE Style 68MP-600 Saline Round Mod 10888628000308, NATRELLE Style 68MP-650 Saline Round Mod 10888628000315, NATRELLE Style 68MP-700 Saline Round Mod 10888628000322, NATRELLE Style 68MP-750 Saline Round Mod 10888628000339, NATRELLE Style 68MP-800 Saline Round Mod 10888628000346,

Published December 25, 2019 · Recall initiated: November 6, 2019

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

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer: Allergan PLC
Distributor: US:AL, AR,AZ,CA,CO,DC,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WY
Lot: MFG BATCH numbers: 2805096 2836786 2884422 2889999 2871740 2878486 2797264 2884426 3036126 3059070 3076451 3124452 3131479 3139882 3154328 3157493 3173220 3176664 3213097 3228743 2776706 2884427 2909055 2921210 3008017 3022733 3035530 3059463 3081093 3096446 3124773 3127774 3142976 3154566 3157086 3157779 3160817 3164079 3167339 3173664 3176918 3182507 3203867 3208283 3211090 3226125 2830860 2868178 2884428 2917776 2958518 2961802 3016093 3019001 3036261 3059268 3076606 3091713 3094037 3124627 3127656 3142812 3148324 3160679 3167175 3189825 3192733 3195360 3210981 3222913 3225690 3228367 2776708 2836794 2884429 2889922 2946579 2954640 2969639 2984574 2996667 3022702 3033348 3036318 3048122 3054598 3059270 3072727 3086874 3094041 3111501 3122044 3124633 3127660 3148328 3157024 3160683 3182357 3185283 3187738 3192736 3194955 3195363 3201094 3210983 3213144 3218861 3220208 3222917 2857336 2861149 2885103 2889923 2930931 2938820 2942044 2947325 2961631 2978758 3033774 3039663 3048103 3059258 3061979 3076599 3086861 3089420 3094030 3096326 3109045 3114260 3122038 3124620 3142805 3150489 3163894 3167170 3170299 3176782 3182348 3189822 3195356 3194950 3201091 3203719 3220198 3222907 3225687 2776710 2780920 2868180 2885104 2920849 2949477 2966841 2978889 2993586 3003249 3025633 3036756 3052473 3059075 3068639 3076456 3093894 3114095 3124453 3127551 3139626 3145481 3148173 3156943 3156819 3157496 3166974 3173225 3176668 3179679 3182211 3187690 3189712 3189474 3208036 3210856 3210531 3210532 2776711 2857338 2868182 2868181 2881296 2880809 2884433 2884432 2908823 2909354 2911816 2964385 2973964 3003294 3016089 3033302 3036337 3047857 3058980 3061727 3072625 3076364 3086598 3093556 3098673 3108882 3111280 3114013 3127484 3131437 3136877 3139820 3148089 3154250 3157421 3160491 3163650 3173123 3176622 3182142 3185096 3189657 3192583 3210808 3213057 3218674 3220001 3222732 2780921 2783860 2790896 2857339 2864408 2868183 2868184 2880812 2881300 2884434 2885106 2895628 2895862 2967070 3025588 3033783 3036348 3047901 3070283 3072669 3080739 3086672 3093866 3096199 3098700 3106592 3108910 3111330 3124423 3127530 3156815 3163685 3170109 3173180 3176648 3182187 3189691 3195201 3197797 3200990 3200514 3205994 3203585 3208012 3210833 3220033 3225555 3228726 3231390 2777081 2787751 2857340 2868185 2868186 2881308 2884435 2884438 2885107 2884437 2911824 2921033 3021479 3025694 3026353 3036758 3047832 3058954 3063355 3068641 3086571 3093549 3093803 3111259 3113996 3121820 3124357 3126992 3127274 3134041 3136855 3139803 3142534 3148066 3150380 3156916 3157406 3157220 3166875 3170053 3173102 3176612 3179617 3182126 3185078 3184838 3187657 3189649 3192574 3194885 3195165 3197763 3200973 3213045 3213482 3218657 3222524 2777082 2790898 2857343 2868190 2880837 2884440 2895644 2908842 2921038 2997339 3009875 3019775 3026410 3033299 3036791 3036396 3042082 3044721 3054558 3080431 3086185 3089183 3093550 3106529 3108866 3108656 3113997 3124358 3126994 3126993 3131422 3156917 3157407 3160472 3160172 3163627 3176613 3184839 3187658 3192167 3194886 3195166 3199812 3200773 3203544 3207960 3219985 3219756 3225518 3234069 2777083 2776714 2868191 2868862 2868192 2881323 2884442 2884441 2909533 2912063 2921211 2930913 2955452 2955037 2974108 2978733 2993925 2996744 3012324 3012325 3047824 3054552 3058677 3064577 3068642 3072600 3086181 3093544 3098654 3098410 3113987 3121814 3126984 3127241 3134033 3133730 3136846 3148058 3150374 3157397 3160165 3166868 3170045 3173095 3176608 3179405 3185070 3184831 3192569 3195159 3197759 3200969 32
Risk classification: Class III
Area (FDA): device
Country: United States

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