| Class 2 Device Recall Exactech | |
Date Initiated by Firm | August 11, 2022 |
Create Date | September 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1734-2022 |
Recall Event ID |
90279 |
510(K)Number | K993082 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
Product | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05;
b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06;
c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07;
d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08;
e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09;
f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04;
g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05;
h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06;
i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07;
j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08;
k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05;
l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06;
m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07;
n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08;
o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09;
p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10;
q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07;
r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08;
s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09;
t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10;
u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05;
v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06;
w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07;
x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08;
y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09;
z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10;
aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05;
bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06;
cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07;
dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08;
ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09;
ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663;
gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664;
hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665 |
Code Information |
a. REF 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982;
b. REF 130-28-06, GUDID 10885862021922, Serial Numbers: 618681, 618682, 618683, 618686, 618688, 618691, 618693, 618696, 618697, 618698, 618699, 618701, 691919, 691920, 691924, 708701, 708703, 708705, 708706, 708707, 708708, 708709, 786731, 786732, 786733, 786740, 786741, 786742, 786743, 786745, 786746, 786747, 786748, 786751, 786752, 786755, 786756, 786758, 786760, 786761, 786762, 1369855, 1369856, 1369857, 1369858, 1369861;
c. REF 130-28-07, GUDID 10885862021939, Serial Numbers: 569785, 569786, 569787, 570965, 570966, 570968, 570970, 570971, 570972, 570973, 570974, 570975, 570976, 570977, 570979, 570980, 570981, 570982, 583427, 583428, 583429, 583430, 583431, 583432, 583434, 583435, 583436, 583437, 583438, 583439, 583441, 583443, 583444, 583445, 583446, 583447, 583448, 583451, 583452, 656293, 656298, 656299, 656302, 656303, 656306, 656307, 656309, 656312, 656314, 712635, 712636, 712637, 712638, 712643, 712644, 712646, 712647, 712650, 712651, 712652, 712657, 712659, 712660, 810722, 810723, 810726, 810727, 810729, 810730, 810731, 810737, 810738, 810739, 810741, 810742, 810743, 810745, 810747, 810748;
d. REF 130-28-08, GUDID 10885862021946, Serial Numbers: 625182, 625185, 625186, 625187, 625192, 625193, 625194, 625195, 625196, 625197, 625206, 625207, 690375, 690376, 690378, 690379, 690380, 765865, 765867, 765868, 765877;
e. REF 130-28-09, GUDID 10885862021953, Serial Numbers: 620518, 620519, 620520, 620522, 620524, 620525, 620528, 620530, 620532, 620534, 620535, 620536, 620538, 681492, 703321, 703331, 703333, 703338;
f. REF 132-22-04, GUDID 10885862022899, Serial Numbers: 622203, 622204, 622205, 622206, 622207, 622208, 622209, 622210, 622211, 622212, 622213, 622214, 622215, 622216, 622217, 622218, 622219, 622220, 622221, 622222, 622223, 622224, 622225, 622226, 622227, 622228, 782728, 782729, 782730, 782731, 782732, 782733, 782734, 782735, 782736, 782737, 782738, 782739, 782740, 782741, 782742, 782743, 782744, 782745, 782746, 782747, 782748, 782749, 782750, 782752, 782753, 782754, 782755, 782756, 782757, 782758, 782759, 954370, 954371, 954372, 954373, 954374, 954375, 954376, 954377, 954378, 954379, 954380, 954381, 954382, 954383, 954384, 954385, 954386, 954387, 954388, 954389, 954390, 954391, 954392, 954393, 954394, 954395, 954396, 954397, 954398, 954399, 954400, 954401, 1061992, 1061993, 1061994, 1061995, 1061996, 1061997, 1061998, 1061999, 1062000, 1062001, 1062002, 1062003, 1062004, 1062005, 1062006, 1062007, 1062008, 1062009, 1062010, 1062011, 1062012, 1062013, 1062014, 1062015, 1062016, 1062017, 1062018, 1062019, 1062020, 1062021, 1062022, 1062023, 1062024, 1062025, 1062026, 1062027, 1062028, 1062029, 1062030, 1062031, 1062032, 1062033, 1062034, 1062035, 1062036, 1062037, 1062038, 1062039, 1062040, 1062041, 1062042, 1062043, 1316908, 1316909, 1316910, 1316911, 1316912, 1316913, 1316914, 1316915, 1316916, 1316917, 1316918, 1316919, 1316920, 1316921, 1316922, 1316923, 1316924, 1316925, 1316926, 1316927, 1359750, 1359751, 1359752, 1359753, 1359754, 1359755, 1359756, 1359757, 1359758, 1359759, 1359760, 1359761, 1359762, 1521378, 1521379, 1521381, 1521382, 1521383, 1521384, 1521385, 1654690, 1654691, 1656126, 1686763, 1686764, 1686765, 1686766, 1686767, 1686768, 1686769, 1686770, 1686771, 1686772, 1686773, 1686774, 1686775, 1686776, 1686777, 1686778, 1686780, 1686781, 1686782, 2040130, 2040131, 2040132, 2040133, 2040134, 2040135, 2040136, 2040137, 2040138, 2040140, 2040141, 2048834, 2048835, 2048836, 2048837, 2173736, 2173737, 2179393, 2188425, 2188426, 2188427, 2198969, 2198970, 2198971, 2198972, 2345255, 2345257, 2345259, 2345261, 2345262, 2345263, 2345264, 2416265, 2416266, 2416267, 2440039, 2440040, 2441288, 2441289, 2441290, 2441291, 2441300, 2441302, 2600716;
g. REF 132-22-05, GUDID 10885862022905, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085.969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059;
h. REF 132-22-06, GUDID 10885862022912, Serial Numbers: 969070, 969075, 969077, 969078, 969079, 969080, 969082, 969083, 969084, 969085, 969087, 969088, 969089, 969091, 969092, 969093, 969094, 969096, 969097, 969098, 2254029, 2254030, 2254032, 2254033, 2254039, 2254040, 2254041, 2254042, 2254043, 2254047, 2254051, 2254052, 2254053, 2254058, 2254059;
i. REF 132-22-07, GUDID 10885862022929, Serial Numbers: 955063, 955064, 955068, 955069, 955072, 955073, 955074, 955077, 955078, 955079, 955083, 955085, 955087, 955088, 955091, 955092, 955093, 2255883, 2255884, 2348261, 2348262, 2348264, 2348265, 2348266, 2348267, 2398399, 2398400, 2398402, 2398404, 2398405, 2398406, 2833459;
j. REF 132-22-08, GUDID 10885862022936, Serial Numbers: 966436, 966437, 966440, 966447, 966450, 966451, 966452, 966456, 966457, 966459, 1614368, 1614369, 1614370, 1614371, 1614372, 1614373, 1614374, 1614375, 2327263, 2327264, 2392929, 2392930, 2392931, 2392932, 2675707, 2675709, 2675711;
k. REF 132-28-05, GUDID 10885862023001, Serial Numbers: 592646, 592647, 592648, 592649, 592650, 592651, 592652, 592653, 592654, 592655, 592657, 602733, 602734, 602735, 602736, 602737, 602738, 602739, 602741, 602742, 602743, 602744, 602745, 602746, 617642, 617643, 617644, 617645, 617646, 617648, 617649, 617650, 617651, 617652, 617653, 617654, 617655, 617656, 617659, 617661, 617662, 617663, 617664, 617665, 647577, 647578, 647579, 647580, 647581, 647582, 647583, 647585, 647586, 647587, 647588, 647589, 647590, 647591, 647592, 647593, 647594, 647597, 647598, 647599, 647601, 647602, 652294, 652297, 652298, 652300, 652301, 652304, 652306, 652307, 652308, 652309, 652310, 652315, 652317, 652318, 665192, 665194, 665195, 665196, 665198, 665199, 665201, 665202, 665203, 665204, 665205, 665206, 665207, 665210, 665212, 685303, 685304, 685305, 685306, 685307, 685308, 685309, 685310, 685312, 685313, 685314, 685316, 685318, 685319, 685321, 685323, 685327, 685328, 685329, 700432, 700436, 700437, 700440, 700442, 700447, 700455, 700457, 700459, 700460, 700461, 700462, 700464, 700465, 700466, 700467, 700468, 700469, 700470, 700471, 700472, 700475, 700476, 700477, 700478, 700480, 700482, 700483, 700484, 700485, 700486, 700487, 700489, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700502, 777001, 777002, 777003, 777004, 777005, 777006, 777007, 777008, 777009, 777010, 777011, 777013, 777014, 777015, 777016, 777017, 777018, 777020, 777021, 777023, 777025, 777026, 777027, 777030, 777031, 810889, 810890, 810892, 810893, 810894, 810896, 810897, 810898, 810900, 810901, 810903, 810904, 810905, 810906, 810907, 810908, 810909, 810910, 810912, 810913, 810915, 810916, 810917, 898467, 898469, 898470, 898475, 898478, 898479, 898480, 898481, 898482, 898483, 898485, 898486, 898487, 898488, 898489, 898490, 898491, 898492, 898493, 898495, 898496, 949430, 949434, 949436, 949439, 949441, 949445, 949447, 949448, 949458, 949460, 949461, 949462, 975898, 975901, 975902, 975903, 975904, 975908, 975912, 1065935, 1065943, 1065952, 1065956, 1065960, 1065961, 1065962, 1229381, 1229383, 1229387, 1229389, 1229390, 1229391, 1229393, 1229394, 1267773, 1267774, 1267775, 1267776, 1267779, 1267780, 1267784, 1267785, 1267788, 1267794, 1267799, 1315265, 1315272, 1315275, 1315276, 1315283, 5021390, 5021393, 5021397, 5021399, 5021400, 5021401, 5021403, 5021405, 5021406, 5021407, 5021408, 5021409, 5021410, 5316432, 5316433, 5316434, 5316435, 5316436, 5316437, 5316438, 5316439, 5316440, 5316441, 5316442, 5316443, 5316444, 5316445, 5316446, 5316447, 5316448, 5316449, 5316450, 5316451, 5448452, 5448454, 5448455, 5448457, 5448459, 5448460, 5448463, 5448465;
l. REF 132-28-06, GUDID 10885862023018, Serial Numbers: 569872, 569873, 569874, 569875, 569876, 569878, 569879, 569880, 569881, 569882, 569885, 569886.569889, 569891, 569892, 569893, 569894, 569895, 581509, 581510, 581511, 581512, 581513, 581514, 581515, 581516, 581523, 581524, 581525, 581526, 581527, 581528, 581529, 581530, 581533, 581534, 581640, 581646, 581647, 581648, 581649, 581652, 581653, 581654, 581655, 581656, 581662, 581666, 581667, 581668, 581669, 581670, 581672, 581673, 581674, 581675, 581676, 581677, 581678, 581679, 581680, 581683, 581684, 581687, 581690, 581691, 581692, 592584, 592585, 592586, 592587, 592588, 592589, 592590, 592591, 592592, 592593, 592594, 592595, 592596, 592597, 592598, 592599, 592600, 592601, 592602, 592603, 592604, 592605, 592698, 592699, 592700, 592701, 592702, 592703, 592704, 592705, 592706, 592707, 592708, 592709, 592710, 592711, 592712, 592713, 592714, 592715, 592716, 592717, 592718, 592719, 592720, 592721, 592722, 592723, 592724, 592725, 592726, 592727, 592728, 592729, 592732, 605920, 605921, 605922, 605923, 605924, 605925, 605926, 605927, 605928, 605929, 605930, 605931, 605933, 605935, 605936, 605937, 605938, 605940, 605942, 605944, 605945, 605946, 605947, 605949, 605950, 605954, 605955, 609451, 609452, 609454, 609458, 609459, 609460, 609461, 609462, 609463, 609464, 609465, 609467, 609468, 609471, 609472, 609473, 609474, 609475, 609477, 609478, 609479, 609480, 614178, 614179, 614184, 614185, 614186, 614187, 614188, 614189, 614190, 614191, 614192, 614194, 614195, 614196, 614198, 617881, 617882, 617883, 617884, 617885, 617889, 617891, 617892, 617893, 617897, 617898, 617899, 617900, 617902, 617903, 617904, 617905, 617906, 617907, 617908, 617909, 617911, 617912, 617913, 617914, 617916, 617917, 617918, 617919, 617920, 617921, 617922, 617923, 617924, 617925, 617926, 617928, 617929, 617930, 617931, 617932, 617933, 617934, 617935, 617936, 617937, 617938, 617939, 617940, 617941, 617942, 617943, 617944, 617946, 626856, 626857, 626858, 626860, 626861, 626862, 626863, 626864, 626865, 626866, 626867, 626868, 626869, 626870, 626871, 626872, 626873, 626874, 626875, 626876, 626877, 626878, 626879, 626880, 626881, 626882, 626883, 626884, 626885, 626886, 626888, 626889, 626890, 626891, 626892, 626893, 626894, 626896, 626897, 626898, 626899, 626900, 626901, 626902, 626903, 626904, 626905, 626906, 626907, 626908, 626909, 626910, 626911, 626912, 626913, 626914, 626915, 626916, 626917, 626918, 626919, 626920, 626921, 626922, 637500, 637501, 637502, 637503, 637504, 637505, 637506, 637507, 637508, 637509, 637510, 637511, 637512, 637513, 637514, 637515, 637516, 637517, 637518, 637519, 637520, 637521, 637522, 637523, 637524, 637525, 637526, 637528, 637529, 637530, 637531, 637532, 637533, 637534, 637535, 637536, 654326, 654327, 654331, 654332, 654333, 654334, 654335, 654336, 654337, 654338, 654339, 654341, 654342, 654347, 654348, 654352, 654356, 654357, 654359, 654366, 654368, 654370, 654371, 654372, 654375, 654377, 654378, 660294, 660295, 660296, 660297, 660298, 660301, 660302, 660305, 660306, 660307, 660308, 660310, 660313, 660314, 660317, 660318, 660319, 660322, 660323, 660324, 660325, 660326, 660327, 660328, 660329, 660330, 660331, 660333, 660334, 660335, 660336, 660337, 660338, 660339, 660340, 660341, 660343, 660345, 660347, 660349, 660353, 660355, 660356, 660360, 660678, 660682, 660683, 660688, 660689, 660692, 660694, 660699, 660700, 660702, 660703, 660704, 660706, 660707, 660708, 660712, 660713, 660717, 660718, 660719, 660722, 660723, 660727, 660728, 660729, 660730, 660733, 660734, 660735, 660736, 667766, 667767, 667768, 667769, 667770, 667771, 667772, 667774, 667775, 667776, 667777, 667778, 667779, 667780, 667781, 667782, 667783, 667784, 667785, 667786, 667787, 667788, 667789, 667790, 667791, 667792, 667793, 667794, 667795, 667796, 667797, 667798, 667799, 667800, 667801, 667802, 667803, 667804, 667805, 667806, 667807, 667808, 667809, 667810, 667811, 667812, 667813, 667814, 667815, 667816, 667817, 667818, 667819, 667820, 667822, 667823, 667824, 667825, 667826, 667827, 667828, 667829, 667830, 667831, 667832, 667833, 667834, 667835, 667836, 667837, 667840.667841, 667842, 667844, 667845, 667846, 667847, 667848, 667849, 667850, 667851, 667852, 667853, 667854, 667855, 667856, 667857, 667858, 667859, 667860, 667861, 667862, 667863, 667864, 667865, 667866, 667867, 667870, 667873, 681026, 681027, 681028, 690676, 690677, 690679, 690680, 690681, 690682, 690683, 690684, 690685, 690686, 690687, 690688, 690689, 690690, 690691, 690692, 690693, 691073, 691076, 691082, 691083, 691084, 691089, 691091, 691094, 691098, 691100, 691102, 691103, 691104, 691105, 691106, 691107, 691109, 691110, 691112, 691113, 691114, 691116, 691117, 699312, 699313, 699314, 699315, 699316, 699317, 699318, 699319, 699320, 699321, 699322, 699323, 699324, 699325, 699326, 699327, 699328, 699331, 699334, 699335, 699337, 699338, 699339, 699343, 699344, 699345, 699346, 699348, 699351, 699352, 699358, 699359, 699360, 699361, 699362, 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5294094, 5294095, 5294096, 5294097, 5294098, 5294099, 5294100, 5492043, 5492044, 5492045, 5492046, 5492047, 5492048, 5492049, 5492050, 5492051, 5492052, 5492053, 5492054, 5492055, 5492056, 5492057, 5492058, 5492059, 5492060, 5492061, 5492062, 5492063, 5492064, 5492065, 5492066, 5492067, 5492068, 5600985, 5600986, 5600987, 5600988, 5600989, 5600990, 5600991, 5600992, 5600993, 5600994, 5600995, 5600996, 5600997, 5600998, 5600999, 5601000, 5601001, 5601002, 5601003, 5601004, 5601005, 5601006, 5601007, 5601008, 5601009, 5601010, 5601011, 5601012, 5601013, 5601014, 5602222, 5602223, 5602224, 5602225, 5602226, 5602227, 5602228, 5602229, 5602230, 5602231, 5602232, 5602233, 5602234, 5602235, 5602236, 5602237, 5602238, 5602239, 5602240, 5602241, 5602242, 5602243, 5602244, 5602245, 5602246, 5602247, 5602248, 5602249, 5602250, 5602251, 5658052, 5658053, 5658054, 5658055, 5658056, 5658057, 5658058, 5658059, 5658060, 5658061, 5658062, 5658063, 5658064, 5658065, 5658066, 5658067, 5658068, 5658069, 5658070, 5658071, 5658072, 5658073, 5658074, 5658075, 5658076, 5658077, 5658078, 5658079, 5658080, 5658081, 5709523, 5709524, 5709525, 5709526, 5709527, 5709528, 5709529, 5709531, 5709532, 5709534, 5709545, 5709546, 5709547, 5709548, 5709549, 5709550, 5709551, 5709552, 5709553, 5709554, 5709555, 5709556, 5709557, 5709558, 5710135, 5710136, 5710137, 5710138, 5710140, 5710141, 5710142, 5710143, 5710144, 5710145, 5710146, 5710147, 5710148, 5710149, 5710151, 5710152, 5710153, 5749008, 5749009, 5749010, 5749011, 5749012, 5749013, 5749014, 5749015, 5749016, 5749017, 5749018, 5749019, 5749020, 5749021, 5749022, 5749023, 5749024, 5749025, 5749026, 5749027, 5749028, 5749029, 5749030;
m. REF 132-28-07, GUDID 10885862023025, Serial Numbers: 569743, 569744, 569745, 569746, 569747, 569748, 569751, 569753, 569755, 569757, 569758, 569759, 569760, 569761, 569762, 569763, 569765, 569766, 575760, 575761, 575762, 575763, 575764, 575765, 575766, 575767, 575769, 575770, 575771, 575772, 575773, 575774, 575775, 575776, 575777, 575778, 575779, 575780, 575781, 575782, 575783, 580163, 580169, 581876, 581877, 581879, 581882, 581883, 581884, 581885, 581887, 581888, 581889, 581890, 581891, 581892, 581893, 581894, 581896, 581897, 581898, 581899, 581900, 581901, 581902, 581904, 581905, 581906, 581907, 585548, 585549, 585550, 585551, 585552, 585553, 585554, 585555, 585556, 585557, 585558, 585559, 585560, 585561, 585562, 585563, 585564, 585565, 585566, 585567, 585568, 585569, 585570, 585571, 594357, 594358, 594359, 594360, 594361, 594362, 594363, 594364, 594365, 594366, 594367, 594369, 594370, 594371, 594372, 594373, 594374, 594375, 594376, 594377, 594378, 594379, 594380, 594381, 594382, 594875, 594876, 594878, 594880, 594881, 594886, 594889, 594893, 594896, 605037, 605038, 605039, 605040, 605041, 605042, 605043, 605044, 605045, 605047, 605048, 605049, 605050, 605051, 605052, 605053, 605054, 605055, 605056, 605057, 605058, 605060, 605061, 605062, 605063, 610394, 610395, 610397, 610398, 610400, 610401, 610402, 610404, 610405, 610406, 610408, 610409, 610413, 610414, 611251, 611252, 611253, 611254, 611255, 611256, 611258, 611259, 611260, 611261, 611262, 611263, 611265, 611266, 611267, 611268, 611269, 611270, 611271, 611272, 611273, 611274, 611275, 611276, 614881, 614882, 614883, 614884, 614885, 614886, 614887, 614888, 614889, 614890, 614891, 614892, 614893, 614894, 614895, 614896, 614897, 614898, 614899, 614900, 614901, 614902, 614903, 614904, 614905, 614906, 614907, 614908, 614909, 614910, 614911, 614912, 614913, 614914, 614915, 614916, 614917, 614918, 614919, 614920, 614921, 614922, 614923, 614924, 614925, 619582, 619583, 619584, 619585, 619586, 619587, 619588, 619589, 619590, 619591, 619592, 619593, 619594, 619595, 619596, 619597, 619599, 619600, 619601, 619603, 619604, 619605, 619606, 619607, 619608, 619609, 619610, 619611, 619612, 619613, 619614, 619615, 619616, 619617, 619618, 619619, 619620, 619621, 619622, 619623, 619624, 628428, 628429, 628430, 628431, 628432, 628433, 628438, 628447, 628448, 628450, 628452, 628455, 628456, 628459, 628460, 628461, 628462, 628463, 628464, 628469, 628471, 628474, 628475, 628476, 628477, 628478, 628480, 640377, 640378, 640379, 640380, 640381, 640382, 640383, 640384, 640385, 640386, 640387, 640388, 640389, 640390, 640391, 640392, 640393, 640394, 640395, 640396, 640397, 640398, 640399, 640400, 640401, 640402, 640404, 640405, 640406, 640407, 640408, 640409, 640410, 640411, 640412, 640413, 655437, 655442, 655443, 655445, 655446, 655448, 655449, 655450, 655453, 655455, 655457, 655463, 655472, 655473, 655474, 664556, 664557, 664558, 664559, 664561, 664566, 664570, 664571, 664579, 664580, 664581, 664582, 664585, 664586, 664587, 664588, 664589, 664590, 664591, 664592, 664593, 664594, 664595, 664596, 664597, 664599, 664600, 664601, 664602, 664603, 664604, 664605, 664606, 664607, 664608, 664609, 664610, 664612, 664614, 664615, 664618, 664619, 664620, 664622, 664623, 664625, 664627, 664629, 664635, 664636, 664637, 664639, 664641, 664642, 664643, 664645, 664704, 664705, 664706, 664707, 664709, 664710, 664711, 664712, 664713, 664714, 664715, 664716, 664717, 664718, 664719, 664720, 664721, 664727, 664728, 664729, 664730, 664731, 664733, 664734, 664737, 664738, 664739, 664740, 664741, 664742, 664743, 664744, 664745, 664747, 664748, 664750, 664752, 664753, 664754, 664755, 664756, 664757, 664758, 664761, 664763, 664764, 664765, 664766, 664767, 664768, 664769, 664770, 664771, 664772, 664773, 664774, 664775, 664776, 664777, 664778, 664779, 664780, 664781, 664782, 664783, 664784, 664785, 664786, 664787, 664788, 664789, 664791, 664792, 664793, 664794, 664795, 664796, 664797, 664798, 664799, 664800, 664801, 664802, 664803, 705687, 705688, 705689, 705690, 705691, 705692, 705694, 705695, 705696, 705697, 705698, 705699, 705700, 705701, 705702, 705703, 705704, 705706, 705707, 705708, 705709, 705710, 706266, 706269, 706270, 706271, 706272, 706274, 706275, 706276, 706277, 706278, 706282, 706283, 706284, 706285, 706287, 706288, 706289, 706290, 706292, 706297, 706301, 706302, 706303, 706304, 706305, 706306, 706307, 706308, 706309, 706310, 706311, 706312, 706313, 706314, 706315, 706316, 706317, 706318, 706321, 706322, 706324, 706325, 706333, 706335, 706338, 706345, 706348, 752178, 752179, 752180, 752181, 752182, 752183, 752184, 752185, 752186, 752187, 752188, 752189, 752190, 752191, 752192, 752193, 752194, 752195, 752196, 752197, 752198, 752200, 752201, 752202, 752203, 752205, 752206, 752207, 752208, 752209, 752210, 752211, 752212, 752213, 752214, 752215, 752216, 752217, 752218, 752219, 752220, 752223, 752224, 752226, 752227, 752228, 752229, 752230, 752231, 752232, 752233, 752234, 752235, 752236, 752237, 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874826, 874827, 874828, 874829, 874831, 874833, 874834, 874835, 874836, 874837, 874838, 874839, 874841, 874843, 874844, 874845, 874846, 892899, 892900, 892901, 892905, 892907, 892908, 892909, 892910, 892912, 892915, 892916, 892917, 892918, 892919, 892920, 892921, 892922, 892924, 892925, 892926, 892927, 892928, 892929, 892930, 892931, 892932, 892934, 892936, 892937, 892938, 892939, 892940, 892944, 892945, 892947, 892949, 892950, 892952, 892953, 893007, 893009, 893012, 893015, 893016, 893018, 893023, 893025, 893026, 893027, 893028, 893033, 893035, 893037, 893038, 893039, 893041, 893042, 893044, 893045, 893046, 893047, 893048, 893049, 893051, 893055, 893056, 893057, 893061, 911346, 911347, 911348, 911349, 911350, 911351, 911352, 911353, 911354, 911355, 911356, 911360, 911362, 911366, 911368, 911372, 911376, 911379, 911380, 911388, 911389, 911390, 911392, 911393, 911394, 911395, 911396, 911397, 911399, 911403, 911404, 911407, 911411, 911412, 911413, 911414, 953956, 953959, 953960, 953961, 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1055041, 1055042, 1055043, 1055044, 1055046, 1055048, 1055049, 1055050, 1055052, 1055057, 1055061, 1055062, 1055074, 1055075, 1055083, 1055086, 1055092, 1055093, 1083732, 1083740, 1083742, 1083743, 1083751, 1083755, 1083758, 1090193, 1090194, 1090196, 1090197, 1090199, 1090201, 1090202, 1090204, 1090206, 1090208, 1090209, 1090210, 1090211, 1090214, 1090215, 1090216, 1090217, 1090218, 1090219, 1090220, 1090221, 1090223, 1090224, 1090225, 1090226, 1090227, 1090232, 1090233, 1090236, 1090237, 1103420, 1103421, 1103422, 1103423, 1103424, 1103425, 1103426, 1103427, 1103428, 1103429, 1103430, 1103431, 1103432, 1103433, 1103434, 1103435, 1103436, 1103437, 1103438, 1118981, 1118984, 1118986, 1118987, 1118988, 1118989, 1118995, 1118997, 1118998, 1119000, 1119003, 1119383, 1119385, 1119386, 1119388, 1119390, 1119391, 1119393, 1119394, 1119397, 1119398, 1119399, 1119404, 1119405, 1129114, 1129115, 1129116, 1145154, 1145160, 1145162, 1145163, 1145164, 1145165, 1145166, 1145169, 1145171, 1145172, 1145176, 1145179, 1145180, 1145183, 1145184, 1145185, 1145186, 1145187, 1145188, 1145189, 1145190, 1145192, 1145193, 1145194, 1145195, 1145196, 1145197, 1145198, 1145202, 1145203, 1145204, 1145206, 1145207, 1145208, 1145209, 1145210, 1145213, 1145215, 1145216, 1145221, 1145222, 1145223, 1145224, 1145225, 1145226, 1145227, 1145228, 1145230, 1145231, 1145232, 1145233, 1145237, 1145239, 1145240, 1145241, 1145243, 1145244, 1145245, 1145246, 1145247, 1145248, 1145249, 1145250, 1145251.1159425, 1159426, 1159434, 1159437, 1159455, 1159456, 1159458, 1159459, 1159460, 1159463, 1197116, 1197117, 1197118, 1197119, 1197120, 1197121, 1197122, 1197123, 1197124, 1197126, 1197127, 1197128, 1197129, 1197130, 1197131, 1197132, 1197133, 1197134, 1197135, 1197136, 1197137, 1197138, 1197139, 1197147, 1197150, 1197153, 1197154, 1197160, 1197161, 1197162, 1197163, 1197164, 1197165, 1197170, 1197171, 1197172, 1197173, 1197174, 1197175, 1197176, 1197177, 1197178, 1197179, 1197180, 1229043, 1229045, 1229047, 1229059, 1229065, 1229067, 1229068, 1229070, 1229071, 1229072, 1229076, 1229078, 1229079, 1229085, 1229088, 1229090, 1229091, 1229095, 1229096, 1229098, 1229099, 1229101, 1229102, 1229103, 1229104, 1229105, 1229106, 1229107, 1229108, 1229109, 1229111, 1229112, 1229115, 1229116, 1229117, 1229118, 1229119, 1229120, 1229121, 1229122, 1229124, 1229125, 1229126, 1244839, 1244859, 1266508, 1266509, 1266510, 1266511, 1266512, 1266514, 1266515, 1266516, 1266519, 1266521, 1266522, 1266524, 1266525, 1266526, 1266531, 1266534, 1266535, 1266537, 1266538, 1266540, 1266541, 1266544, 1266545, 1266546, 1266547, 1266548, 1266550, 1266551, 1266552, 1266554, 1266555, 1266560, 1266561, 1266562, 1266563, 1266564, 1266566, 1266567, 1266569, 1287278, 1287279, 1287283, 1287286, 1287287, 1287288, 1287289, 1287296, 1287299, 1287300, 1287301, 1287303, 1287304, 1287306, 1287307, 1287310, 1287311, 1287312, 1287314, 1287315, 1287317, 1287318, 1287320, 1287321, 1287322, 1287325, 1287327, 1287328, 1287331, 1287332, 1287333, 1287335, 1287337, 1287338, 1287340, 1287519, 1287520, 1287522, 1287524, 1287526, 1287528, 1287530, 1287534, 1287535, 1287536, 1287538, 1287539, 1287540, 1287541, 1287542, 1287547, 1287548, 1287549, 1287551, 1287554, 1287557, 1287558, 1287559, 1287561, 1287563, 1287566, 1287569, 1287572, 1287575, 1287576, 1287578, 1287579, 1287580, 1287581, 1287583, 1328553, 1328557, 1328560, 1328562, 1328563, 1328564, 1328565, 1328568, 1328569, 1328570, 1328575, 1328579, 1328580, 1328581, 1328585, 1328587, 1328588, 1328589, 1328593, 1328597, 1328598, 1328599, 1328600, 1328602, 1328603, 1328604, 1328605, 1328606, 1328611, 1328613, 1328614, 1328615, 1328617, 1349645, 1349647, 1349649, 1349650, 1349652, 1349653, 1349654, 1349656, 1349659, 1349660, 1349663, 1349664, 1349665, 1349666, 1349667, 1349668, 1349669, 1349670, 1349671, 1349672, 1349673, 1349675, 1349676, 1349677, 1349678, 1349679, 1349680, 1349681, 1349682, 1349683, 1349684, 1349685, 1349686, 1349687, 1349688, 1349689, 1349690, 1349691, 1349692, 1349693, 1349694, 1349695, 1349696, 1349697, 1349698, 1349699, 1349700, 1349701, 1349703, 1349704, 1349705, 1349706, 1349707, 1349708, 1374944, 1374945, 1374947, 1374949, 1374950, 1374951, 1374952, 1374953, 1374956, 1374959, 1374961, 1374971, 1374974, 1374975, 1374978, 1374979, 1374980, 1374983, 1374984, 1374985, 1374986, 1374987, 1374991, 1374993, 1374994, 1374997, 1374998, 1375000, 1375001, 1375002, 1375003, 1375004, 1375005, 1375006, 1404419, 1404420, 1404421, 1404422, 1404423, 1404424, 1404425, 1404426, 1404427, 1404428, 1404429, 1404430, 1404431, 1404432, 1404433, 1404434, 1404435, 1404436, 1404437, 1411425, 1411428, 1411429, 1411432, 1411433, 1411438, 1411443, 1411445, 1411447, 1411448, 1411449, 1411458, 1411459, 1411460, 1411461, 1411463, 1411464, 1411465, 1411466, 1411468, 1411469, 1411473, 1411474, 1411476, 1411478, 1411479, 1411480, 1411481, 1446653, 1446654, 1446655, 1446657, 1446658, 1446661, 1446663, 1446664, 1446666, 1446668, 1446669, 1446670, 1446675, 1446676, 1446678, 1446679, 1446686, 1446687, 1446688, 1446689, 1446695, 1446699, 1446700, 1446701, 1446702, 1446704, 1446705, 1446706, 1446707, 1446708, 1446709, 1446710, 1446711, 1446712, 1446713, 1446714, 1446715, 1446716, 1446717, 1446718, 1446719, 1446721, 1446722, 1446723, 1446724, 1446725, 1446726, 1446727, 1446728, 1446729, 1446730, 1481551, 1481552, 1481553, 1481554, 1481555, 1481556, 1481557, 1481558, 1481559, 1481560, 1481561, 1481562, 1481563, 1481564, 1481565, 1481566, 1481567, 1481568, 1481569, 1481570, 1481571, 1481572, 1481573, 1481574, 1481575, 1481576, 1481577, 1493206, 1493228, 1538451, 1540800, 1540801, 1556835, 1556841, 1604039, 1666550, 1666551, 1666552, 1666553, 1666554, 1666555, 1666556, 1666557, 1666559, 1666560, 1666566, 1666568, 1666569, 1666570, 1666571, 1666572, 1666574, 1666576, 1666577, 1666578, 1666579, 1666580, 1666581, 1666582, 1666583, 1666584, 1666585, 1666587, 1666588, 1666589, 1666591, 1666593, 1666595, 1666596, 1687380, 1687381, 1687399, 1687401, 1687414, 1764107, 1764141, 1764143, 1764148, 1794987, 2170654, 2170655, 2170663, 2426869, 2426885, 2434313, 2523794, 2558239, 2759936, 2784380, 4529924, 4529927, 4529929, 4529931, 4529936, 4994821, 4994822, 4994823, 4994824, 4994825, 4994826, 4994827, 4994828, 4994829, 4994830, 4994831, 4994832, 4994833, 4994834, 4994835, 4994836, 4994837, 4994838, 4994839, 5245301, 5350045, 5350046, 5350047, 5350048, 5693576, 5693577, 5693580, 5693581, 5693582, 5693583;
n. REF 132-28-08, GUDID 10885862023032, Serial Numbers: 567410, 567412, 567413, 567414, 567417, 567419, 567420, 567421, 567422, 567424, 567425, 567426, 567428, 567429, 567432, 567434, 567435, 576265, 576268, 576269, 576271, 576274, 576276, 576277, 576278, 576279, 576280, 576281, 576282, 576289, 578344, 578345, 578347, 578348, 578349, 578350, 578351, 578352, 578353, 578354, 578356, 578357, 578358, 578361, 578362, 578363, 578365, 578366, 578368, 601900, 601901, 601902, 601903, 601904, 601905, 601906, 601907, 601910, 601911, 601924, 601925, 603533, 603535, 603536, 603539, 603540, 603541, 603542, 603544, 603545, 603549, 603551, 603552, 610785, 610786, 610788, 610789, 610790, 610792, 610797, 610798, 610799, 610803, 610804, 610805, 610806, 610807, 610808, 610809, 610810, 610811, 620641, 620642, 620643, 620644, 620645, 620646, 620647, 620649, 620650, 620651, 620652, 620654, 620655, 620656, 620657, 620660, 620661, 620662, 620663, 639586, 639588, 639589, 639591, 639596, 639605, 639606, 639607, 639610, 655087, 655088, 655089, 655090, 655091, 655092, 655093, 655094, 655095, 655096, 655098, 655099, 655100, 655101, 655102, 655104, 655105, 655106, 655107, 655108, 655110, 655111, 655112, 655113, 673309, 673310, 673311, 673312, 673313, 673314, 673315, 673316, 673318, 673321, 673323, 673326, 673328, 673329, 673331, 673334, 673335, 673336, 673337, 673338, 673339, 673340, 673341, 673344, 673346, 673347, 673350, 673351, 673352, 673354, 673356, 673357, 673358, 673359, 673360, 673361, 673362, 673363, 673364, 673366, 673367, 673368, 673369, 673370, 673371, 673372, 673373, 673374, 673375, 673376, 673378, 673379, 673380, 673381, 673382, 673383, 673384, 690288, 690293, 690295, 690297, 690299, 690300, 690304, 690308, 690309, 690310, 690311, 690313, 705252, 705253, 705254, 705255, 705257, 705258, 705260, 705261, 705262, 705265, 705266, 705267, 705268, 705269, 705272, 705273, 705275, 705276, 705282, 705283, 705284, 705285, 705286, 705287, 705288, 705289, 705293, 705294, 705295, 706642, 706643, 706644, 706645, 706646, 706647, 706648, 706649, 706650, 706651, 706652, 706653, 706654, 706656, 706657, 716662, 716663, 716665, 716667, 716668, 716669, 757143, 757202, 757205, 757206, 757207, 757211, 757215, 757216, 757218, 757220, 757222, 757224, 757225, 757226, 757229, 757231, 757232, 757233, 757235, 789489, 789490, 789492, 789493, 789495, 789497, 789498, 789499, 789501, 789502, 789503, 789504, 789506, 789508, 789509, 789510, 789511, 789512, 789513, 789514, 789516, 789517, 789518, 789519, 789520, 789521, 789522, 789523, 789524, 789526, 789527, 789530, 789533, 789534, 890063, 890064, 890065, 890066, 890067, 890068, 890069, 890072, 890073, 890074, 890075, 890076, 890078, 900988, 900992, 900995, 900997, 901001, 901004, 901005, 901007, 901008, 901009, 901010, 901011, 901012, 901013, 901016, 901017, 901018, 901019, 903171, 903172, 903173, 903178, 903180, 903181, 903182, 903183, 903184, 903186, 903190, 903192, 903193, 903195, 903196, 903198, 903199, 903200, 961196, 961198, 961199, 961200, 961201, 961203, 961204, 961205, 961206, 961207, 961208, 961209, 961212, 961214, 961215, 965509, 965511, 965513, 965516, 965517, 965518, 965521, 965522, 965523, 965524, 965525, 965530, 965531, 973745, 973746, 973747, 973748, 973751, 973752, 973753, 973754, 973755, 973756, 973757, 973761, 973762, 973765, 973769, 973770, 973771, 973772, 973773, 973774, 973775, 973776, 973778, 973779, 973781, 973782, 973783, 973788, 973790, 973794, 973796, 973797, 973798, 1027034, 1027035, 1027036, 1027038, 1027041, 1027043, 1027046, 1027047, 1027048, 1027050, 1027051, 1041531, 1041532, 1041534, 1041536, 1041538, 1041539, 1041540, 1041542, 1041544, 1041548, 1041552, 1041553, 1041554, 1041556, 1041557, 1041559, 1041560, 1041562, 1041564, 1041565, 1041569, 1041570, 1041572, 1041573, 1041574, 1041575, 1041583, 1041586, 1041587, 1041589, 1041591, 1041592, 1041593, 1041594, 1077810, 1077811, 1077812, 1077813, 1077815, 1077816, 1077817, 1077818, 1077820, 1077821, 1077822, 1077824, 1077825, 1077826, 1077827, 1077828, 1077829, 1077830, 1077832, 1077833, 1077835, 1077836, 1077837, 1077838, 1077839, 1131773, 1131796, 1147129, 1147130, 1147132, 1147133, 1147134, 1147137, 1147138, 1147141, 1147142, 1147146, 1147147, 1147149, 1147152, 1147159, 1147161, 1192617, 1192618, 1192619, 1192621, 1192623, 1192624, 1192626, 1192627, 1192630, 1192631, 1192632, 1192633, 1192634, 1192635, 1192636, 1192637, 1192638, 1192639, 1192641, 1192642, 1192643, 1192644, 1192647, 1226545, 1226547, 1226549, 1226550, 1226551, 1226554, 1226556, 1226559, 1226560, 1226561, 1226562, 1226563, 1226565, 1226566, 1226568, 1226570, 1226572, 1226574, 1226575, 1226576, 1226577, 1226578, 1226584, 1226586, 1226587, 1226592, 1226593, 1245560, 1245562, 1245563, 1245566, 1245567, 1245569, 1245571, 1245572, 1245573, 1245575, 1245576, 1245578, 1245579, 1245580, 1245581, 1245583, 1245585, 1245587, 1245590, 1289122, 1289125, 1289127, 1289131, 1289132, 1289133, 1289134, 1289137, 1289138, 1289139, 1289141, 1289143, 1289144, 1289145, 1289147, 1289148, 1289150, 1289151, 1289152, 1320286, 1320287, 1320289, 1320290, 1320291, 1320292, 1320295, 1320297, 1320298, 1320299, 1320304, 1320305, 1320306, 1320307, 1320308, 1320309, 1320312, 1320314, 1320316, 1320317, 1320318, 1357045, 1357047, 1357048, 1357050, 1357051, 1357055, 1357056, 1357058, 1357059, 1357060, 1357063, 1357064, 1357065, 1357068, 1357069, 1357070, 1357072, 1357073, 1357074, 1357076, 1358049, 1358050, 1358051, 1358052, 1358053, 1358054, 1358055, 1358056, 1358057, 1358058, 1358059, 1358060, 1358061, 1358062, 1358063, 1358064, 1358066, 1358067, 1358068, 1358069, 1358070, 1358071, 1358072, 1358073, 1358076, 1358077, 1358078, 1358080, 1358081, 1416007, 1416008, 1416009, 1416010, 1416011, 1416012, 1416013, 1416014, 1416015, 1416016, 1416017, 1416018, 1416019, 1416020, 1416021, 1416022, 1416023, 1416024, 1416025, 1416026, 1416027, 1416028, 1416029, 1416030, 1416031, 1416032, 1416033, 1416034, 1416035, 1416036, 1416037, 1416038, 1416039, 1487165, 1487166, 1487167, 1487168, 1487171, 1487172, 1492638, 1492639, 1492640, 1492641, 1492642, 1492643, 1492644, 1492646, 1492647, 1635618, 1635619, 1635620, 1635621, 1635623, 1635624, 1635628, 1635629, 1635630, 1635633, 1635637, 1635638, 1635639, 1635641, 1635642, 1635643, 1635644, 1635645, 1635646, 1635647, 1635648, 1635649, 2775300, 2795026, 2795027, 2795028, 2795029, 4117343, 5245396, 5350035, 5350036, 5350037, 5998885;
o. REF 132-28-09, GUDID 10885862023049, Serial Numbers: 621622, 621623, 621624, 621625, 621626, 621628, 621629, 621630, 621631, 621632, 621633, 621634, 621635, 621636, 621637, 621638, 621639, 621640, 621641, 621642, 621643, 621644, 621646, 621647, 621648, 657725, 657726, 657727, 657728, 657729, 657730, 657731, 657732, 657733, 657736, 657737, 657738, 657740, 657741, 657742, 657743, 657745, 657746, 657747, 657748, 657749, 657750, 690261, 690262, 690263, 690264, 690265, 690268, 690272, 690274, 690275, 690276, 690277, 690278, 690279, 690280, 690281, 690282, 716235, 716236, 716239, 716240, 716243, 716244, 716246, 716248, 716249, 716251, 716252, 716256, 716257, 716258, 716259, 716260, 716261, 716262, 716263, 949014, 949016, 949017, 949019, 949020, 949024, 949026, 949027, 949028, 949029, 949030, 949031, 949032, 949034, 949035, 949036, 949037, 949038, 949039, 949041, 949042, 949044, 999457, 999458, 999459, 999460, 999461, 999462, 999463, 999464, 999465, 999466, 999467, 999468, 999471, 999472, 999473, 999474, 999476, 999477, 999479, 999481, 999482, 999483, 999484, 999485, 999486, 999487, 1083218, 1083219, 1083222, 1083223, 1083224, 1083225, 1083226, 1083227, 1083229, 1083231, 1083232, 1083233, 1083234, 1083235, 1083236, 1083237, 1083238, 1083239, 1083240, 1083241, 1083243, 1083244, 1083246, 1083247, 1083248, 1083249, 1083250, 1358341, 1358343, 1358344, 1358345, 1358346, 1358347, 1358348, 1358349, 1358350, 1358351, 1358352, 1358353, 1358354, 1358355, 1487174, 1487175, 1487176, 1487177, 1487178, 1487179, 1487180, 1487181, 1487182, 1487183, 1487184, 1487186, 1487187, 1487189, 1487190, 1487191, 1487192, 1487193, 1492674, 1492675, 1492676, 1492677, 1492678, 1516556, 1516562, 1669246, 2836481, 2836482, 3852265, 3852270, 3874054, 3874055, 3874057, 5998888, 5998889;
p. REF 132-28-10, GUDID 10885862023056, Serial Numbers: 997540, 997542, 997544, 997546, 997547, 997548, 997549, 997550, 997553, 997554, 997555, 997558, 997559, 997563, 997565;
q. REF 132-32-07, GUDID 10885862023209, Serial Numbers: 580324, 580325, 580326, 580327, 580328, 580329, 580330, 580331, 580332, 580333, 580334, 580335, 580336, 580337, 580338, 580339, 580340, 580341, 580342, 580343, 580344, 580345, 580346, 580347, 580348, 592606, 592607, 592608, 592609, 592610, 592611, 592612, 592613, 592614, 592615, 592616, 592617, 592618, 592619, 592620, 592621, 592622, 592624, 592625, 592626, 592627, 592629, 592630, 592631, 609828, 609829, 609830, 609831, 609832, 609833, 609834, 609835, 609836, 609837, 609838, 609839, 609840, 609842, 609843, 609844, 609845, 609846, 609847, 609848, 609849, 609850, 609851, 609852, 609853, 609854, 615509, 615510, 615511, 615512, 615513, 615515, 615516, 615517, 615518, 615519, 615520, 615521, 615522, 615523, 615524, 615525, 615526, 615527, 615528, 615529, 615531, 615532, 615533, 617580, 617581, 617582, 617583, 617584, 617585, 617586, 617587, 617588, 617589, 617590, 617592, 617593, 617594, 617595, 617596, 617597, 617598, 617599, 617600, 617601, 617602, 617603, 617604, 617605, 627136, 627137, 627138, 627139, 627140, 627141, 627142, 627143, 627144, 627145, 627146, 627147, 627148, 627149, 627150, 627151, 627152, 627153, 627154, 627155, 627156, 627157, 627158, 627159, 627160, 627161, 627162, 656186, 656187, 656188, 656189, 656190, 656191, 656192, 656193, 656194, 656195, 656196, 656197, 656198, 656199, 656200, 656201, 656202, 656203, 656204, 656205, 656206, 656207, 656208, 656209, 656210, 656211, 656212, 662481, 662482, 662483, 662484, 662485, 662486, 662487, 662488, 662489, 662490, 662491, 662492, 662493, 662494, 662495, 662496, 662497, 662498, 662499, 662500, 662501, 662502, 662503, 688359, 688360, 688361, 688362, 688363, 688364, 688365, 688366, 688367, 688368, 688369, 688370, 688372, 688373, 688374, 688375, 688376, 688377, 688378, 688743, 688744, 688745, 688746, 688747, 688748, 688749, 688750, 688751, 688752, 688753, 688754, 688755, 688756, 688757, 688758, 688759, 688760, 688761, 688762, 688763, 688764, 688765, 688766, 688767, 694847, 694848, 694849, 694850, 694851, 694852, 694853, 694854, 694855, 694856, 694857, 694858, 694859, 694860, 694862, 694863, 694865, 694866, 710888, 710889, 710890, 710891, 710892, 710893, 710894, 710896, 710897, 710898, 710899, 710900, 710901, 710902, 710903, 710904, 710905, 710906, 710907, 710908, 710909, 710910, 710911, 710912, 710913, 710914, 710915, 710916, 723948, 723949, 723950, 723952, 723953, 723954, 723955, 723956, 723957, 723958, 723959, 723960, 723961, 723962, 723963, 723964, 723966, 723967, 723968, 723969, 723970, 723971, 723972, 723973, 723974, 741147, 741148, 741149, 741150, 741151, 741152, 741153, 741154, 741155, 741156, 741157, 741158, 741159, 741160, 741161, 741162, 741163, 741164, 741166, 741167, 741169, 741170, 741171, 741172, 741173, 741174, 754592, 754593, 754594, 754595, 754596, 754597, 754598, 754599, 754600, 754601, 754602, 754603, 754604, 754605, 754606, 754607, 754608, 754609, 754610, 754611, 754612, 754613, 754614, 754615, 754616, 754617, 754618, 754619, 763398, 763400, 763401, 763402, 763404, 763405, 763406, 763407, 763408, 763409, 763410, 763411, 763412, 763413, 763414, 763415, 763416, 763418, 763419, 763420, 763421, 779156, 788973, 788974, 788975, 788978, 788979, 788980, 788983, 788984, 788985, 788986, 788987, 788988, 788991, 788992, 788993, 788994, 788996, 808695, 808697, 808700, 808702, 808705, 808709, 808712, 808717, 808718, 808719, 1357034, 4676845, 4681569, 4681572, 4681576, 5041588, 5041589, 5041591, 5431509, 5431510, 5431511, 5431512, 5431513, 5431514, 5486961, 5684712, 5684713, 5684714, 5684715, 5684716, 5684717, 5684718, 5684719, 5684720, 5684721, 5974725, 6087673, 6087674, 6087675, 6087676, 6117817, 6117818, 6117819, 6117820, 6117821, 6117822, 6117824, 6117826, 6117827, 6117828, 6117830, 6117831, 6117832, 6117833, 6117835, 6117836, 6117837, 6117838;
r. REF 132-32-08, GUDID 10885862023216, Serial Numbers: 578012, 578013, 578014, 578015, 578016, 578017, 578018, 578019, 578020, 578021, 578022, 578023, 578024, 578025, 578026, 578027, 578028, 578029, 578030, 578031, 578032, 578033, 578034, 578035, 578036, 578037, 602452, 602453, 602454, 602455, 602456, 602457, 602458, 602459, 602460, 602461, 602462, 602464, 602466, 602467, 602468, 602469, 602470, 602472, 602473, 602474, 602475, 602476, 602477, 602478, 615112, 615115, 615118, 615119, 615120, 615121, 615123, 615125, 615127, 615129, 615130, 615131, 615133, 615134, 620485, 620486, 620487, 620489, 620490, 620491, 620493, 620494, 620495, 620496, 620497, 620498, 620499, 620501, 620502, 620503, 620504, 620505, 620506, 620507, 620508, 620509, 620510, 620511, 656103, 656104, 656105, 656106, 656107, 656108, 656110, 656111, 656112, 656113, 656114, 656115, 656116, 656117, 656118, 656119, 656120, 656121, 656122, 656123, 656124, 656125, 656126, 656127, 656128, 656129, 684879, 684880, 684881, 684882, 684885, 684886, 684887, 684888, 684890, 684891, 684893, 684894, 684895, 684896, 684897, 684898, 684900, 684902, 684903, 689233, 689235, 689236, 689237, 689238, 689243, 689247, 689248, 689249, 689250, 689253, 689256, 689257, 689259, 689262, 689263, 689269, 689272, 689273, 689274, 689275, 689278, 689279, 689281, 689282, 689284, 689286, 689287, 689292, 751832, 751835, 751839, 751840, 751841, 751843, 751847, 751853, 751855, 751859, 751860, 751868, 751870, 751875, 790569, 790571, 790572, 790573, 790581, 790582, 790591, 5142816, 5142817, 5142818, 5142819, 5142820, 5998884, 6117839, 6117841, 6117844, 6117846, 6117848, 6117854, 6117855, 6117857, 6117863, 6117864;
s. REF 132-32-09, GUDID 10885862023223, Serial Numbers: 607030, 607031, 607034, 607036, 607038, 607040, 607042, 607043, 607045, 607046, 607047, 607049, 607051, 607052, 607054, 607055, 607056, 619897, 619898, 619899, 619900, 619901, 619903, 619904, 619905, 619906, 619907, 619909, 619910, 619915, 619917, 619918, 619920, 619921, 657570, 657572, 657573, 657575, 657576, 657578, 657579, 657580, 657581, 657585, 657586, 657587, 657590, 657591, 657592, 657593, 689807, 689809, 689810, 689811, 689812, 689820, 689823, 689824, 689826, 689827, 689828, 689829, 689830, 689831, 689839, 689840, 689841, 689843, 689847, 689848, 689850, 5998886, 5998887;
t. REF 132-32-10, GUDID 10885862023230, Serial Numbers: 604388, 604396, 604397, 604402, 604405;
u. REF 134-28-05, GUDID 10885862023841, Serial Numbers: 681495, 691551, 691552, 691554, 691555, 691556, 691557, 713760, 713761, 713766, 800818, 800823, 800826;
v. REF 134-28-06, GUDID 10885862023858, Serial Numbers: 652911, 652912, 652913, 652914, 652915, 652916, 652917, 652918, 652919, 652923, 652924, 652931, 652932, 652933, 652934, 691929, 691931, 691933, 691934, 691936, 691938, 691939, 691945, 691950, 691954, 691955, 691957, 691958, 805851, 805858, 805864, 805865, 805868, 805871, 805873, 805874, 805875, 805876;
w. REF 134-28-07, GUDID 10885862023865, Serial Numbers: 615567, 615569, 615570, 615571, 615572, 615576, 615577, 615578, 615579, 615580, 615581, 615582, 615584, 615588, 615589, 661637, 661638, 661639, 661640, 661641, 661642, 661643, 661644, 661645, 661646, 661650, 661651, 661653, 661654, 661655, 661656, 661657, 661658, 661660, 684905, 694132, 694134, 694137, 694139, 694146, 694147, 694148, 702396, 702399, 702409, 702421;
x. REF 134-28-08, GUDID 10885862023872, Serial Numbers: 601951, 601952, 601953, 601954, 601955, 601956, 601957, 601961, 601963, 601967, 601968, 601970, 601971, 601972, 660817, 660836, 660839, 660840, 689947, 689951, 689952, 689965, 689969, 689971;
y. REF 134-28-09, GUDID 10885862023889, Serial Numbers: 579099, 579101, 579102, 579106, 579107, 579115, 579118, 579122, 579123, 689512, 689516, 689517, 689520, 689521, 689527, 689528, 757874, 757878, 757889;
z. REF 134-28-10, GUDID 10885862023896, Serial Numbers: 756401;
aa. REF 138-28-05, GUDID 10885862024510, Serial Numbers: 768326, 768327, 768329,
768336, 768337, 768339, 1314739, 1314756, 1314762;
bb. REF 138-28-06, GUDID 10885862024527, Serial Numbers: 799541;
cc. REF 138-28-07, GUDID 10885862024534, Serial Numbers: 661145, 661158, 661159;
dd. REF 138-28-08, GUDID 10885862024541, Serial Numbers: 669318, 669342;
ee. REF 138-28-09, GUDID 10885862024558, Serial Numbers: 826518;
ff. REF CSK-1663, GUDID 10885862118035, Serial Numbers: 568673, 568674, 568675, 568676, 568678, 568679, 568680, 568681, 568682, 568683, 568684, 568685, 568686, 568687, 568688, 568689, 568690, 568691, 580812, 580813, 580814, 580817, 580820, 580821, 580822, 580823, 580824, 611773, 611774, 611776, 643104, 643105, 643106, 643107, 643108, 643109, 643110, 643112, 643114, 696318, 696319, 696320, 696322, 696323, 696324, 696325, 697066, 697067, 697069, 697070, 697071, 697072, 697074, 697075, 697080;
gg. REF CSK-1664, GUDID 10885862118042, Serial Numbers: 580723, 580725, 580726, 580727, 580729, 580730, 580733, 580734, 580735, 580736, 580737, 580738, 580739, 580740, 580741, 580742, 580744, 580745, 580746, 580747, 580749, 580750, 580752, 595698, 696743, 696744, 696745, 696746, 696748, 696749, 696750, 696751, 696754, 696755, 696756;
hh. REF CSK-1665, GUDID 10885862118059, Serial Numbers: 594993, 594994, 594995, 594996, 594997, 594998, 594999, 595000, 595001, 614823, 614826, 614827, 614828, 614833, 614835.
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Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 Nw 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | 888-912-0403 |
Manufacturer Reason for Recall | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. |
FDA Determined Cause 2 | Process control |
Action | The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices.
The Customers were instructed to take the following actions:
CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required.
IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory.
EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession.
COMPLETE AND RETURN the attached Recall Inventory Response Form to
Exactech via email at recalls@exac.com.
Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods
(RG) Number for ALL affected product requested to be returned.
WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL.
If you have any questions, call (888) 912-0403. |
Quantity in Commerce | 7946 devices |
Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON
PORTUGAL,PUERTO RICO,SPAIN
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JDI
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