GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP,

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. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

Lot/Code Info: a. REF 106-22-42, GUDID 10885862014337, Serial Numbers: 609855, 609856, 609857, 609858, 609859, 609860, 609862, 609863, 609864, 609865, 609867, 609868, 609869, 609870, 609871, 609873, 609874, 609878, 609879, 609880, 914353, 914354, 914355, 914356, 914357, 914358, 914359, 914360, 914361, 914362, 914363, 914364, 996721, 996722, 996723, 996724, 996725, 996726, 996727, 996728, 996730, 996731, 996732, 996733, 996734, 996735, 996736, 996737, 996738, 996739, 1049244, 1049245, 1049246, 1049247, 1068758, 1068759, 1068760, 1068761, 1068762, 1068763, 1068765, 1068766, 1068767, 1068768, 1068769, 1068770, 1068771, 1068772, 1068773, 1068774, 1068775, 1068776, 1068777, 1068778, 1229946, 1229947, 1229948, 1229949, 1229950, 1229951, 1229952, 1229953, 1229954, 1229955, 1229956, 1332136, 1332137, 1332138, 1332139, 1332140, 1358473, 1358475, 1358476, 1358477, 1358478, 1514277, 1514278, 1514279, 1514280, 1514281, 1514282, 1514283, 1514284, 1514285, 1514286, 1514287, 1514288, 1514289, 1514290, 1514291, 1514292, 1514293, 1514296, 1695633, 1695634, 1695635, 1695636, 1695637, 1695638, 1695639, 1695640, 1695642, 1695643, 1695644, 1695645, 1695646, 1695647, 1695648, 1695649, 1695650, 1695651, 1695652, 1919868, 1919869, 1919870, 1919871, 1919872, 1919873, 1919874, 1919875, 2017771, 2017772, 2172423, 2172424, 2172425, 2180478, 2180479, 2180480, 2180481, 2221234, 2221235, 2221236, 2221238, 2276137, 2276138, 2276139, 2291938, 2291939, 2291940, 2291941, 2333843, 2333844, 2375620, 2375621, 2375622, 2375623, 2387651, 2426847, 2426848, 2426849, 2426851, 2426853, 2426857, 2426858, 2426860, 2426861, 2523731, 2523732, 2523733, 2523734, 2523735, 2523736, 2523737, 2523741, 2829861; b. REF 106-22-44, GUDID 10885862014344, Serial Numbers: 639981, 639983, 639984, 639985, 639987, 639988, 639991, 639992, 639993, 639996, 639997, 640000, 640001, 640003, 640004, 640005, 640006, 817951, 817952, 817953, 817954, 817955, 817956, 817957, 817958, 817959, 817960, 817961, 817962, 817963, 817964, 817965, 817966, 817967, 817968, 817969, 817970, 817971, 817972, 817973, 817974, 817975, 817976, 817977, 817978, 817979, 918337, 918338, 918339, 918340, 918341, 918342, 947926, 947927, 947928, 948966, 948967, 948968, 948969, 948970, 948971, 948972, 948973, 953468, 953469, 953470, 953471, 953472, 953473, 953474, 953475, 953476, 953477, 953478, 983886, 983887, 983889, 983890, 983891, 983892, 983893, 983894, 983895, 983896, 983897, 1030464, 1030465, 1030466, 1030467, 1030468, 1030469, 1030471, 1030472, 1030474, 1030475, 1063471, 1063472, 1063473, 1063474, 1063475, 1063476, 1063477, 1063478, 1063479, 1063480, 1091417, 1091418, 1091419, 1091420, 1091421, 1091422, 1091423, 1091424, 1091425, 1091426, 1091427, 1144552, 1144553, 1144554, 1144555, 1144556, 1144557, 1144558, 1144559, 1144560, 1144561, 1144562, 1144563, 1148822, 1148823, 1148824, 1148825, 1148826, 1148828, 1148829, 1148830, 1148831, 1148832, 1216991, 1216992, 1216993, 1216994, 1216995, 1216996, 1216997, 1216998, 1216999, 1217000, 1217001, 1331966, 1331967, 1331968, 1331969, 1331970, 1337238, 1337239, 1337240, 1337241, 1337242, 1338262, 1338263, 1338264, 1338265, 1338266, 1400016, 1400017, 1400018, 1400019, 1400020, 1508752, 1508753, 1508754, 1508755, 1508756, 1508757, 1508758, 1508759, 1508760, 1508761, 1508762, 1508764, 1508765, 1508766, 1508767, 1508768, 1546724, 1546725, 1546726, 1546727, 1546728, 1546729, 1546730, 1564097, 1564098, 1564099, 1564100, 1564101, 1564102, 1564103, 1564105, 1564106, 1564107, 1679331, 1679332, 1679333, 1679334, 1679335, 1679336, 1679337, 1679338, 1679339, 1679340, 1679341, 1679342, 1679343, 1679344, 1679347, 1679348, 1679351, 1679352, 1907549, 1907550, 1907552, 1907553, 1907554, 1907555, 1907556, 1907557, 1907558, 1907560, 1907561, 1907563, 1907564, 1907565, 1907566, 1907567, 1919619, 1919620, 1919621, 1919623, 2190916, 2190917, 2197909, 2197910, 2229307, 2230911, 2230920, 2260548, 2425073, 2425074, 2425075, 2425076, 2425077, 2579301, 2579302, 2579306, 2797305; c. REF 106-22-46, GUDID 10885862014351, Serial Numbers: 607057, 607058, 607062, 607065, 607066, 607067, 607069, 607073, 607074, 607079, 639619, 639621, 639622, 639623, 639624, 639625, 639626, 639627, 639628, 639629, 639630, 639631, 639632, 639633, 639635, 639636, 639637, 639638, 639640, 639641, 639642, 639643, 814278, 814279, 814280, 814281, 814282, 814283, 814284, 814285, 814286, 814287, 814288, 814289, 814290, 814291, 814292, 814293, 814294, 814295, 814296, 814297, 814298, 822453, 822454, 822455, 822457, 822458, 822459, 822460, 822461, 822464, 822465, 822466, 822467, 822468, 822469, 822470, 822471, 822472, 822473, 822474, 822475, 822476, 822477, 822478, 822479, 822480, 822481, 930825, 930827, 930828, 930829, 930831, 930832, 937984, 937985, 937986, 937987, 937988, 937989, 937990, 937991, 937992, 945802, 945803, 945804, 945805, 945806, 945807, 945808, 945809, 945810, 945811, 945812, 956906, 956907, 956908, 956909, 956910, 956911, 956912, 956913, 956914, 982576, 982577, 982578, 982579, 982580, 982581, 982582, 982584, 982585, 982586, 982587, 982588, 982589, 982590, 982591, 982592, 982593, 982594, 982595, 982596, 982597, 982598, 982599, 982600, 982601, 982602, 1020386, 1020387, 1020388, 1020389, 1020390, 1020391, 1020392, 1020393, 1020394, 1020395, 1020396, 1020397, 1040911, 1040912, 1040913, 1040914, 1040915, 1040916, 1040917, 1040918, 1040919, 1040920, 1040921, 1056598, 1056599, 1056600, 1056601, 1056602, 1056603, 1056604, 1056605, 1056606, 1056607, 1056608, 1084693, 1084694, 1084695, 1084696, 1084698, 1084699, 1084700, 1084701, 1084702, 1084703, 1084704, 1115005, 1115007, 1115008, 1115009, 1115010, 1115011, 1115012, 1115013, 1115014, 1115015, 1115016, 1115017, 1115018, 1115019, 1115020, 1115021, 1115022, 1115023, 1115024, 1115025, 1115026, 1195302, 1195303, 1195304, 1195305, 1195306, 1195308, 1195309, 1195310, 1195311, 1195313, 1231387, 1231388, 1231389, 1231390, 1231391, 1231392, 1231394, 1231395, 1231396, 1231398, 1295838, 1295839, 1295840, 1295841, 1295842, 1295843, 1295844, 1295845, 1295846, 1295848, 1295849, 1332944, 1332945, 1332946, 1332947, 1332948, 1332949, 1332950, 1332951, 1332952, 1367686, 1367687, 1367688, 1367689, 1367690, 1367691, 1367692, 1367693, 1367694, 1367695, 1367696, 1434641, 1434642, 1434643, 1434644, 1434645, 1434646, 1434647, 1434648, 1434649, 1434650, 1434651, 1434652, 1434653, 1434654, 1434655, 1434656, 1434657, 1434658, 1434659, 1528220, 1528221, 1528222, 1528223, 1528224, 1528225, 1528226, 1528227, 1528228, 1528229, 1540020, 1540021, 1540022, 1540023, 1540025, 1540026, 1746252, 1746253, 1746254, 1746255, 1746256, 1746257, 1746258, 1746259, 1746260, 1746261, 1746262, 1746263, 1761788, 1761789, 1761790, 1761791, 1761792, 1761793, 1761794, 1761796, 1761797, 1761798, 1761799, 1761800, 1761801, 1761802, 1761803, 1761804, 1761805, 1761806, 1761807, 1761808, 1761810, 1761811, 1761812, 1761813, 1761815, 1761816, 1827034, 1827035, 1827036, 1827037, 1827038, 1827039, 1827040, 1827041, 1919732, 1919733, 1919734, 1919735, 1919738, 1919740, 1919741, 1919742, 1919744, 1919745, 2190157, 2190158, 2190161, 2212091, 2245100, 2245101, 2245102, 2245103, 2245104, 2245105, 2245106, 2245107, 2357013, 2357014, 2357015, 2418195, 2418196, 2418198, 2418199, 2418200, 2481252, 2481255, 2481257, 2481258, 2481259, 2481260, 2575378, 2575383, 2575384; d. REF 106-22-48, GUDID 10885862014368, Serial Numbers: 947421, 947422, 947424, 947425, 947426, 947428, 947429, 947437, 947442, 947445, 1688077, 1688078, 1688079, 1688081, 1688083, 1688084, 2168203; e. REF 106-22-50, GUDID 10885862014375, Serial Numbers: 905492, 905497, 905499, 905500, 905503, 905505, 905514, 2062753, 2062757, 2062767, 2062773; f. REF 106-22-52, GUDID 10885862014382, Serial Numbers: 949166, 949171, 949173, 949174, 949176, 1970347, 1970348, 967454, 967459; h. REF 106-28-48, GUDID 10885862014603, Serial Numbers: 595247, 595248, 595249, 595250, 595251, 595252, 595253, 595254, 595255, 595256, 595258, 595259, 595260, 595261, 595262, 595263, 595264, 595265, 595266, 595267, 595268, 595269, 595270, 595271, 595272, 614753, 614754, 614755, 614756, 614757, 614758, 614759, 614760, 614761, 614762, 614763, 614764, 614765, 614766, 614767, 614768, 614769, 614770, 614771, 614772, 614773, 614774, 614775, 614776, 614777, 614778, 640037, 640038, 640039, 640040, 640041, 640043, 640044, 640045, 640046, 640047, 640048, 640049, 640050, 640051, 640052, 640053, 640054, 640055, 640056, 640057, 640058, 640059, 640060, 640061, 641727, 641728, 641732, 641733, 641734, 641735, 641736, 641738, 641739, 641740, 641741, 641742, 641743, 641744, 641745, 641746, 641747, 641749, 641750, 641751, 669109, 669110, 669111, 669112, 669113, 669114, 669115, 669116, 669118, 669119, 669120, 669121, 669123, 669124, 669125, 669126, 669127, 669128, 669130, 669131, 669133, 669134, 669135, 669136, 669137, 669138, 669139, 669140, 669141, 669142, 669143, 669145, 669146, 669147, 669148, 669149, 669150, 669151, 669152, 669153, 669155, 669156, 669157, 669159, 669160, 669161, 669162, 722795, 722801, 722803, 722804, 722805, 722806, 722807, 722808, 722809, 722811, 722813, 722814, 722815, 722816, 722817, 722818, 722819, 722820, 722821, 766147, 766148, 766149, 766150, 766151, 766152, 766153, 766154, 766155, 766156, 766157, 766158, 766159, 766160, 766161, 766162, 766163, 766164, 766165, 766166, 766167, 766168, 766170, 766171, 766172, 766173, 766174, 766175, 766176, 766177, 785164, 785165, 785166, 785167, 785168, 785169, 785170, 785171, 785172, 785173, 785174, 785175, 785176, 785177, 785178, 785179, 785180, 785181, 785182, 785183, 785184, 785185, 785186, 785187, 785188, 785189, 785190, 785191, 785192, 785193, 834529, 834530, 834531, 834532, 834533, 834534, 834535, 834536, 834537, 834538, 834540, 834541, 834542, 834543, 834544, 834545, 834546, 834547, 834548, 834549, 834550, 834551, 834552, 834553, 834554, 834555, 834556, 834557, 834558, 835047, 835048, 835049, 835050, 835051, 835052, 835053, 835054, 835055, 835056, 835057, 835058, 835059, 835060, 835061, 835062, 835063, 835064, 835065, 835066, 871522, 871523, 871524, 871525, 871526, 871527, 871528, 871529, 871530, 871531, 871532, 871533, 871534, 871535, 871536, 871537, 871538, 871539, 871540, 871541, 873630, 873632, 873635, 873636, 873637, 873638, 873639, 873641, 873642, 873644, 873646, 873647, 873648, 873649, 873650, 909097, 909099, 909100, 909101, 909102, 909103, 909104, 909105, 909106, 909107, 909109, 909110, 909111, 909289, 909290, 909291, 909292, 909293, 909294, 909295, 909296, 909297, 909298, 909299, 909302, 909303, 909305, 909306, 918295, 918296, 918297, 918298, 918299, 918300, 918301, 918302, 918303, 918304, 918305, 918306, 918307, 923172, 923173, 923174, 923175, 923176, 923177, 923178, 923179, 923180, 923181, 923182, 923183, 923184, 928326, 928327, 928328, 928329, 928330, 928331, 928332, 928333, 928334, 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1380472, 1380473, 1380474, 1380475, 1380476, 1380477, 1380478, 1380479, 1422668, 1422669, 1422670, 1422671, 1422672, 1422673, 1422674, 1422677, 1422678, 1422679, 1422680, 1422681, 1422682, 1422683, 1422684, 1422685, 1422686, 1422687, 1422688, 1422689, 1422690, 1422691, 1422692, 1422693, 1422694, 1422695, 1422696, 1422697, 1422698, 1422699, 1436601, 1436602, 1436603, 1436604, 1436605, 1436607, 1436608, 1436609, 1436610, 1436611, 1436612, 1436613, 1436614, 1436615, 1472630, 1472631, 1472632, 1472634, 1472635, 1472636, 1472637, 1472638, 1472639, 1472640, 1472642, 1472643, 1472644, 1472646, 1472647, 1472648, 1472649, 1472650, 1472651, 1472652, 1472653, 1472654, 1472655, 1472656, 1472657, 1472658, 1472659, 1495116, 1495117, 1495118, 1495119, 1495120, 1495121, 1495122, 1495123, 1495124, 1495126, 1495127, 1495129, 1495130, 1495131, 1495132, 1495133, 1495134, 1495135, 1495137, 1495138, 1495139, 1495140, 1495141, 1495142, 1495143, 1495144, 1495145, 1495146, 1495147, 1495148, 1495149, 1495150, 1495151, 1495152, 1495153, 1495154, 1495155, 1495156, 1495157, 1495158, 1495160, 1495161, 1495162, 1539268, 1539269, 1539270, 1539271, 1539272, 1539273, 1539274, 1539275, 1539276, 1539277, 1557051, 1557052, 1557053, 1557054, 1557055, 1557056, 1557057, 1557059, 1557060, 1600159, 1600160, 1600161, 1600162, 1600163, 1600164, 1600165, 1600166, 1600167, 1600168, 1600169, 1600170, 1600171, 1600172, 1600173, 1600174, 1600175, 1600176, 1600177, 1600179, 1600180, 1600181, 1600182, 1600183, 1600184, 1600185, 1600186, 1600187, 1603039, 1603040, 1603041, 1603042, 1603043, 1603044, 1603045, 1603046, 1603049, 1603050, 1603051, 1603052, 1603053, 1603054, 1603055, 1603056, 1603057, 1603058, 1603059, 1603060, 1603061, 1603062, 1645107, 1645108, 1645109, 1645110, 1645111, 1645112, 1645113, 1645114, 1645115, 1645116, 1645117, 1645118, 1645119, 1645120, 1645121, 1645122, 1645123, 1645124, 1645125, 1645126, 1645127, 1645128, 1645129, 1645130, 1645131, 1645132, 1645133, 1645134, 1645135, 1645136, 1645137, 1645138, 1645139, 1645140, 1645141, 1673735, 1673736, 1673737, 1673738, 1673739, 1673740, 1673741, 1673742, 1673743, 1673744, 1673745, 1673746, 1673747, 1673748, 1673749, 1673750, 1673751, 1673752, 1673753, 1673754, 1673755, 1714664, 1714665, 1714666, 1714667, 1714668, 1714669, 1714670, 1714671, 1714672, 1714673, 1714674, 1714675, 1714676, 1714677, 1714678, 1714679, 1714680, 1714681, 1714682, 1714683, 1714684, 1714685, 1714686, 1714687, 1714688, 1714689, 1714690, 1714691, 1714692, 1714693, 1714694, 1714695, 1714696, 1714697, 1714698, 1714699, 1714700, 1714701, 1714702, 1714703, 1737913, 1737914, 1737915, 1737916, 1737917, 1737918, 1737919, 1737920, 1737921, 1737922, 1737923, 1737924, 1737925, 1737926, 1737927, 1737928, 1737929, 1737930, 1737931, 1737932, 1737933, 1737934, 1752696, 1752697, 1752698, 1752699, 1752700, 1752701, 1752702, 1752703, 1752704, 1752705, 1752707, 1752708, 1752709, 1752710, 1752711, 1752712, 1752713, 1752714, 1752715, 1752716, 1752717, 1752718, 1756145, 1756146, 1756148, 1756149, 1756150, 1756151, 1756152, 1756153, 1756154, 1756155, 1756156, 1756157, 1756158, 1756159, 1756160, 1756161, 1756162, 1756164, 1756165, 1756166, 1756167, 1756168, 1756169, 1835155, 1835156, 1835157, 1835158, 1835159, 1835160, 1835161, 1835162, 1835164, 1835165, 1835166, 1835167, 1835168, 1835169, 1835170, 1835172, 1835174, 1835175, 1835177, 1835178, 1835179, 1835180, 1835181, 1835182, 1835183, 1835184, 1835185, 1835186, 1835187, 1835188, 1835189, 1835190, 1835191, 1835192, 1835193, 1835194, 1835195, 1835196, 1835197, 1835198, 1835199, 1835200, 1835201, 1835233, 1835234, 1835235, 1835236, 1835237, 1835238, 1835239, 1835240, 1835241, 1835242, 1835243, 1835244, 1835245, 1835246, 1835247, 1835248, 1835249, 1835250, 1835251, 1835252, 1835253, 1835254, 1835255, 1835256, 1835257, 1835258, 1835259, 1835261, 1835262, 1835263, 1835264, 1835265, 1835266, 1835267, 1835268, 1835269, 1835270, 1853054, 1853055, 1853056, 1853057, 1853058, 1853059, 1853060, 1853061, 1853062, 1853063, 1853064, 1853066, 1853067, 1853068, 1853069, 1853070, 1853071, 1853072, 1924397, 1924398, 1924399, 1924400, 1924402, 1924403, 1924405, 1924410, 1924411, 1924412, 1924413, 1924414, 1924415, 1924417, 1924418, 1924419, 1924420, 1924528, 1924529, 1924530, 1924531, 1924532, 1924533, 1924534, 1924535, 1924536, 1924537, 1924538, 1924539, 1924540, 1924541, 1924542, 1924543, 1924544, 1924545, 1924546, 1924547, 1924548, 1924549, 1924550, 1924551, 1924552, 2000985, 2000986, 2000987, 2000988, 2000989, 2000990, 2000991, 2000992, 2000993, 2000994, 2000995, 2000996, 2000997, 2000998, 2000999, 2001000, 2001001, 2001002, 2001003, 2001004, 2001005, 2001006, 2012063, 2012064, 2012066, 2012067, 2012068, 2012069, 2012070, 2012071, 2012072, 2012073, 2012074, 2012075, 2012076, 2012077, 2012078, 2012079, 2012080, 2012081, 2012082, 2012083, 2012084, 2012085, 2012086, 2012087, 2012090, 2012091, 2026323, 2026324, 2026325, 2026326, 2026327, 2026328, 2026329, 2026330, 2026331, 2026332, 2026333, 2026334, 2026335, 2026336, 2026337, 2026338, 2026339, 2026340, 2026341, 2026342, 2048839, 2048840, 2048841, 2048842, 2048843, 2048844, 2048845, 2048846, 2048847, 2048848, 2048849, 2048850, 2048851, 2048852, 2048853, 2048854, 2048855, 2048856, 2048857, 2048858, 2241438, 2241439, 2241440, 2241441, 2241442, 2241443, 2241444, 2241445, 2241446, 2241447, 2241448, 2241449, 2241450, 2241451, 2241452, 2241453, 2241454, 2241455, 2241456, 2241457, 2241458, 2241459, 2241460, 2241461, 2241462, 2241463, 2241464, 2241465, 2241466, 2241467, 2291709, 2291710, 2291711, 2291713, 2291714, 2291715, 2291716, 2291717, 2291718, 2291719, 2291720, 2291721, 2291723, 2291724, 2291725, 2291726, 2314707, 2314708, 2314709, 2314710, 2314711, 2314712, 2314713, 2314715, 2314716, 2314717, 2314718, 2314720, 2314721, 2314722, 2314723, 2314724, 2398418, 2398419, 2398420, 2398421, 2398422, 2398423, 2405530, 2405531, 2405532, 2405534, 2405535, 2405536, 2405537, 2405538, 2405539, 2405540, 2405541, 2405542, 2405543, 2405544, 2405545, 2405546, 2405547, 2405548, 2405549, 2405550, 2405551, 2405552, 2405553, 2405554, 2405555, 2405556, 2405557, 2405558, 2405559, 2405560, 2405562, 2405563, 2405564, 2405565, 2405566, 2468070, 2468071, 2468072, 2468073, 2468074, 2468075, 2468076, 2468077, 2468078, 2468079, 2468080, 2468081, 2468082, 2468083, 2468084, 2468085, 2468086, 2468087, 2468088, 2468089, 2468090, 2468091, 2468092, 2468093, 2537329, 2537330, 2537331, 2537332, 2537333, 2537334, 2537335, 2537336, 2537337, 2537338, 2537339, 2537340, 2537341, 2537342, 2537343, 2537344, 2537345, 2537346, 2537347, 2537348, 2537349, 2537350, 2537351, 2537352, 2537353, 2537354, 2537355, 2537356, 2537357, 2537358, 2537359, 2537360, 2537361, 2537362, 2537363, 2537364, 2537365, 2537366, 2537367, 2537368, 2537369, 2537370, 2537371, 2575385, 2575386, 2575387, 2575388, 2575389, 2575390, 2575391, 2575392, 2575393, 2575394, 2575395, 2575396, 2575397, 2575398, 2575399, 2575401, 2575403, 2575404, 2575405, 2575406, 2575407, 2575408, 2575409, 2575410, 2849245, 2849246, 2849247, 2849248, 2849249, 2849251, 2849252, 2849253, 2849254, 2849255, 2849256, 2849257, 2849258, 2849259, 2849260, 2849261, 2849262, 2849263, 2849264, 2849265, 2849267, 2849268, 2849269, 2849270, 2959363, 2959365, 2959366, 2959367, 2959368, 2959369, 2959370, 2959372, 2959373, 2978295, 2978296, 2978297, 2978298, 2978299, 2978300, 2978301, 2978302, 2978303, 2978304, 2978305, 2978307, 2978308, 3536218, 3536219, 3536220, 3536223, 3536224, 3536225, 3536226, 3536229, 3536230, 3536231, 3536234, 3536237, 3536238, 3536240, 3707448, 3707450, 3707452, 3707454, 3707456, 3707457, 3812884, 3812885, 3812886, 3812887, 3812888, 3812889, 3812890, 3812891, 3812892, 3812893, 3812894, 3812895, 3862847, 3862848, 3862849, 3862850, 3862851, 3862852, 3862853, 3862854, 3862855, 3862856, 3862857, 3862859, 3862860, 3862861, 3862862, 3862864, 4086226, 4086227, 4086228, 4086229, 4086230, 4086231, 4086232, 4086233, 4086234, 4086235, 4086236, 4086237, 4162297, 4162298, 4162299, 4162300, 4162301, 4162302, 4162303, 4162304, 4162306, 4162307, 4162308, 4162309, 4162310, 4162311, 4162312, 4162313, 4162314, 4162315, 4162316, 4162317, 4162318, 4162319, 4162320, 4162321, 4162322, 4162323, 4321334, 4321335, 4321336, 4321337, 4321338, 4321339, 4321340, 4321341, 4321342, 4321343, 4321344, 4321345, 4321346, 4321347, 4321348, 4321349, 4321350, 4321351, 4321352, 4321353, 4476701, 4476702, 4476703, 4476704, 4476705, 4476706, 4476707, 4476708, 4476709, 4476710, 4476711, 4476712, 4476713, 4476714, 4476715, 4476716, 4476717, 4476718, 4672669, 4672670, 4672671, 4672672, 4672673, 4672674, 4672675, 4672676, 4672677, 4672678, 4672679, 4672680, 4672681, 4672682, 4672683, 4672684, 4672685, 4672686, 4672687, 4672689, 4672690, 5145624, 5145625, 5145626, 5145627, 5145628, 5145629, 5145630, 5145631, 5145632, 5145633, 5262539, 5262542, 5262543, 5262546, 5262547, 5262548, 5262549, 5262551; i. REF 106-28-50, GUDID 10885862014610, Serial Numbers: 598300, 598301, 598302, 598303, 598304, 598305, 598307, 598310, 598311, 598312, 598313, 598314, 598315, 598316, 598318, 598319, 598321, 598323, 598324, 622440, 622441, 622442, 622443, 622444, 622445, 622446, 622447, 622448, 622450, 622451, 622452, 622453, 622454, 622455, 622456, 622457, 622458, 622459, 622460, 643323, 643324, 643325, 643326, 643328, 643329, 643330, 643331, 643332, 643333, 643334, 643335, 643336, 643338, 643339, 643340, 643341, 643343, 643344, 643345, 643346, 643347, 643348, 676868, 676869, 676870, 676871, 676872, 676873, 676875, 676876, 676877, 676878, 676879, 676880, 676882, 676883, 676884, 676885, 676886, 676887, 676888, 676890, 676892, 676893, 676894, 676895, 676896, 676897, 676898, 676899, 676901, 676902, 676903, 676904, 676905, 676906, 676908, 676909, 676910, 676911, 676912, 676913, 676914, 676915, 676916, 676917, 676918, 676919, 777095, 777096, 777099, 777100, 777101, 777102, 777103, 777104, 777105, 777106, 777107, 777108, 777109, 777110, 777111, 777112, 777113, 777114, 777115, 777116, 777117, 777118, 777119, 777120, 777122, 785363, 785364, 785365, 785366, 785367, 785368, 785369, 785370, 785371, 785372, 785373, 785374, 785376, 785378, 785379, 785380, 785381, 785382, 785383, 785384, 845487, 845488, 845489, 845490, 845491, 845492, 845493, 845494, 845495, 845496, 845498, 845499, 845501, 845502, 845503, 845504, 845506, 845508, 845744, 845745, 845746, 845747, 845748, 845749, 845750, 845752, 845753, 845754, 845755, 845756, 845757, 845758, 845759, 845760, 845762, 845763, 845765, 845766, 845767, 845768, 845771, 845772, 845773, 845774, 845775, 943041, 943043, 943044, 943045, 943046, 943048, 943149, 943150, 943151, 943152, 943153, 943154, 968773, 968774, 968775, 968776, 968777, 968778, 968779, 968780, 968782, 995692, 995693, 995694, 995695, 995696, 995697, 995698, 995699, 995700, 995701, 995702, 995703, 995704, 995705, 995706, 995707, 995708, 995709, 995710, 995711, 995712, 995713, 995714, 995715, 995716, 995717, 995718, 995719, 995720, 995721, 995722, 1026593, 1026594, 1026595, 1026596, 1026597, 1026598, 1026599, 1026600, 1026601, 1026602, 1026603, 1026604, 1026606, 1026607, 1026608, 1026609, 1054364, 1054365, 1054366, 1054368, 1054369, 1054370, 1054371, 1054372, 1054373, 1054374, 1055253, 1055254, 1055255, 1055256, 1055257, 1072647, 1072648, 1072649, 1072650, 1072651, 1072652, 1072653, 1072654, 1072655, 1072656, 1072657, 1072658, 1072659, 1072660, 1072662, 1072663, 1072664, 1072665, 1072666, 1072667, 1072668, 1091400, 1091401, 1091402, 1091403, 1091404, 1091405, 1091406, 1091407, 1091408, 1091409, 1091410, 1091411, 1091412, 1091413, 1091414, 1091416, 1106177, 1106178, 1106179, 1106180, 1106181, 1106182, 1106184, 1106186, 1106187, 1106188, 1116976, 1116977, 1116978, 1116979, 1116980, 1116981, 1116983, 1116984, 1116985, 1116986, 1116988, 1116989, 1116990, 1116991, 1116992, 1122280, 1122281, 1122282, 1122283, 1122284, 1122285, 1122286, 1122288, 1122289, 1122290, 1122291, 1159487, 1159488, 1159489, 1159490, 1159491, 1159492, 1159493, 1159494, 1159495, 1159496, 1159497, 1159498, 1159499, 1159500, 1159501, 1159502, 1201388, 1201389, 1201390, 1201391, 1201392, 1201393, 1201395, 1201396, 1201397, 1201398, 1201399, 1201400, 1201401, 1201402, 1201403, 1201404, 1201405, 1227839, 1227840, 1227842, 1227843, 1227844, 1227845, 1227846, 1227848, 1227849, 1227850, 1227851, 1227852, 1227853, 1227854, 1233275, 1233276, 1233277, 1233278, 1233279, 1233280, 1233281, 1233282, 1233283, 1233284, 1233285, 1233286, 1233288, 1233289, 1233290, 1233291, 1233292, 1233293, 1233294, 1233295, 1233296, 1233297, 1233298, 1233299, 1233300, 1233302, 1233303, 1276058, 1276059, 1276060, 1276061, 1276062, 1276063, 1276064, 1276065, 1276066, 1276067, 1276068, 1276069, 1294949, 1294950, 1294951, 1294953, 1294954, 1294955, 1294956, 1294957, 1294958, 1294959, 1294960, 1294961, 1294963, 1332059, 1332060, 1332061, 1332062, 1332063, 1332064, 1332065, 1332066, 1332067, 1332068, 1332069, 1332070, 1332071, 1332072, 1332073, 1332074, 1332075, 1369611, 1369612, 1369613, 1369614, 1369615, 1369616, 1369618, 1369619, 1369620, 1369621, 1369622, 1369623, 1369625, 1369626, 1369627, 1369628, 1369629, 1369630, 1369631, 1369632, 1369634, 1369635, 1369636, 1369637, 1369639, 1369640, 1369641, 1484400, 1484401, 1484402, 1484403, 1484404, 1484405, 1484406, 1484407, 1484408, 1484409, 1484410, 1484411, 1484412, 1504127, 1504128, 1504129, 1504130, 1504131, 1504132, 1504134, 1504135, 1504136, 1504137, 1504139, 1504140, 1504141, 1504144, 1504146, 1504147, 1504148, 1517230, 1517231, 1517232, 1517233, 1517234, 1517235, 1517236, 1517237, 1517238, 1517239, 1517240, 1605945, 1605947, 1605948, 1605949, 1605950, 1605951, 1605952, 1605953, 1605954, 1605955, 1605956, 1605957, 1605959, 1605960, 1607881, 1607882, 1607883, 1607884, 1607885, 1607886, 1607887, 1607888, 1607889, 1607890, 1607891, 1607892, 1607893, 1607894, 1607895, 1607896, 1607897, 1607898, 1607899, 1607900, 1607901, 1607902, 1607903, 1607904, 1607905, 1607906, 1607907, 1607908, 1607909, 1607910, 1607911, 1659558, 1659559, 1659560, 1659562, 1659563, 1659564, 1659565, 1659566, 1659567, 1659568, 1659569, 1659570, 1659571, 1659572, 1659574, 1659575, 1659576, 1659577, 1659578, 1745805, 1745806, 1745807, 1745808, 1745809, 1745810, 1745811, 1745812, 1745813, 1745814, 1745815, 1745816, 1745817, 1745818, 1745819, 1745820, 1745821, 1745822, 1745823, 1745824, 1745826, 1745827, 1745829, 1745831, 1745832, 1745833, 1745834, 1745835, 1745836, 1745837, 1745838, 1745839, 1745840, 1745841, 1745842, 1745843, 1745844, 1762027, 1762028, 1762029, 1762030, 1762031, 1762032, 1762033, 1762034, 1762035, 1762036, 1762037, 1762038, 1762040, 1762041, 1762042, 1762043, 1762044, 1784861, 1784862, 1784863, 1784865, 1784866, 1784867, 1784868, 1784869, 1784870, 1812666, 1812668, 1812669, 1812671, 1812675, 1812676, 1812677, 1812679, 1812680, 1812683, 1909088, 1909089, 1909090, 1909091, 1909092, 1909093, 1909094, 1909095, 1909097, 1911592, 1911593, 1911594, 1911595, 1911596, 1911597, 1911598, 1911599, 1911600, 1911601, 1911602, 1911603, 1911604, 1911605, 1911606, 1911607, 1911608, 1911609, 1911612, 1911613, 1911616, 2026916, 2026917, 2026918, 2026919, 2026920, 2173767, 2173768, 2173770, 2173771, 2173772, 2173773, 2173774, 2173775, 2188826, 2188827, 2188828, 2188830, 2188831, 2188832, 2188833, 2188834, 2188835, 2188837, 2188838, 2188840, 2188841, 2188842, 2188843, 2188844, 2188845, 2221687, 2221688, 2221689, 2221690, 2221691, 2221692, 2221693, 2221694, 2221696, 2221697, 2221698, 2221699, 2221700, 2221701, 2221702, 2221703, 2221704, 2221705, 2277455, 2277456, 2277458, 2277459, 2277460, 2277461, 2277462, 2277463, 2277464, 2277465, 2314391, 2314392, 2314393, 2314396, 2314397, 2314398, 2314399, 2420460, 2420461, 2420462, 2420463, 2420464, 2420465, 2420466, 2420467, 2420468, 2420469, 2420470, 2420471, 2420472, 2420473, 2420474, 2420475, 2420476, 2420477, 2420478, 2420479, 2505298, 2505299, 2505301, 2505302, 2505303, 2505304, 2505306, 2505308, 2505309, 2505310, 2505311, 2505312, 2505313, 2505316, 2505318, 2505319, 2505320, 2505321, 2505322, 2575411, 2575412, 2575413, 2575414, 2575415, 2575416, 2575417, 2575418, 2575419, 2575420, 2575422, 2575423, 2575424, 2575425, 2575426, 2575427, 2797359, 2797360, 2797362, 2797363, 2797364, 2797366, 2797367, 2797368, 2849271, 2849272, 2849273, 2849274, 2849275, 2849276, 2849277, 2849278, 2849280, 2849281, 2849282, 2849283, 2849284, 2849285, 2849286, 2849287, 2849288, 2849289, 2849290, 2849291, 2849292, 2849293, 2849294, 2849295, 2849296, 2953208, 2995324, 2995326, 2995329, 2995332, 2995333, 2995335, 2995336, 2995339, 2995341, 2995342, 2995343, 3990939, 4028350, 4028351, 4028352, 4028353, 4028354, 4028355, 4028356, 4028357, 4028358, 4028359, 4207498, 4207499, 4207500, 4207501, 4207502, 4207503, 4207504, 4207505, 4207506, 4207507, 4207508, 4207509, 4207510, 4207511, 4207512, 4207513, 4207514, 4207515, 4207516, 4207517, 4618012, 4618013, 4618014, 4618015, 4618016, 4618017, 4618018, 4949457

Quantity Affected: 4956 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