GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM,

Summary

The FDA issued a Class II for GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: by Exactech, Inc.. Reason: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear..

Details

Product Description

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

Lot/Code Info: 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, 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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

Quantity Affected: 7946 devices

Reason for Recall

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-08-11

Company