GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM

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. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

Lot/Code Info: a. REF 134-28-41, GUDID 10885862023971, Serial Numbers: 1152706, 1152707, 1152709, 1152711, 1152712, 1152713, 1152714, 1152716, 1152717, 1152719, 1152721, 1152722, 1152724, 1152725, 1338587, 1338588, 1338589, 1338590, 1338592, 1338593, 1338594, 1338595, 1338598, 1338599, 1338600, 1338601, 1338602, 1338603, 1338604, 1504513, 1504516, 1514969, 1514972, 1521171, 1521172, 1521173, 1521174, 1521175, 1521176, 1521177, 1521178, 1521179, 1521180, 1521181, 1665721, 1665722, 1665723, 1665724, 1665725, 1665728, 1665730, 1665732, 1665733, 1665734, 1665735, 1665737, 1665738, 1821757, 1821758, 1821759, 1821762, 1821763, 1821764, 1834478, 1834479, 1834480, 1834481, 1834482, 1834483, 1834484, 1834486, 1834487, 1916424, 1916425, 1916426, 1916428, 1916429, 1916430, 1916431, 1916432, 1916433, 1916434, 1916435, 1916436, 1916437, 1916438, 1916439, 1916440, 1916441, 2023328, 2023329, 2023330, 2023331, 2023332, 2023333, 2048938, 2048939, 2049268, 2064326, 2064327, 2064328, 2064329, 2064330, 2064332, 2067222, 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4886437, 4886439, 4886440, 4886441, 4886443, 4886444, 4886445, 4886446, 4886447, 4886448, 4886449, 4886450, 4886451, 4886452, 5128950, 5128951, 5128952, 5128953, 5128954, 5128955, 5128956, 5128957, 5128958, 5128959, 5175908, 5175909, 5175910, 5175911, 5175912, 5175913, 5175914, 5175915, 5175917, 5335272, 5335273, 5335274, 5335275, 5335276, 5335277, 5335278, 5335279, 5335280, 5335282, 5335283, 5335284, 5335285, 5335286, 5335287, 5335288, 5335289, 5335290, 5335291, 5335292, 5335293, 5335294, 5335295, 5335296, 5335297, 5335299, 5335300, 5440692, 5440693, 5440694, 5440695, 5440696, 5440697, 5440698, 5440700, 5440702, 5440703, 5440704, 5504861, 5504863, 5504864, 5504865, 5504867, 5504868, 5504869, 5504870, 5504872, 5594159, 5594160, 5594161, 5594162, 5594163, 5594164, 5594165, 5594166, 5594167, 5594169, 5594170, 5641743, 5641744, 5641746, 5641747, 5641748, 5641749, 5641752, 5641754, 5641755, 5641756, 5735870, 5735871, 5735872, 5735873, 5735874, 5735875, 5735876, 5735877, 5735878, 5735879, 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REF 134-32-42, GUDID 10885862023988, Serial Numbers: 1152933, 1152935, 1152936, 1152937, 1152938, 1152939, 1152940, 1152941, 1152942, 1152943, 1152944, 1152945, 1152946, 1152947, 1152948, 1152949, 1152950, 1332353, 1332354, 1332355, 1332356, 1332357, 1332358, 1332359, 1332360, 1332361, 1332362, 1332363, 1332364, 1332366, 1332367, 1332368, 1332370, 1332371, 1332372, 1363147, 1363148, 1363150, 1363151, 1363154, 1363156, 1363157, 1363158, 1363159, 1363160, 1363162, 1363163, 1363165, 1363166, 1499570, 1499571, 1499572, 1499575, 1517160, 1517162, 1517163, 1517164, 1517165, 1517166, 1589904, 1589905, 1589906, 1589907, 1589908, 1589909, 1589911, 1589912, 1589914, 1589916, 1589918, 1589920, 1589921, 1589922, 1589923, 1589927, 1589928, 1589929, 1589930, 1589931, 1589933, 1589934, 1589935, 1641526, 1641529, 1641530, 1641531, 1641533, 1641534, 1641535, 1641536, 1641537, 1641540, 1653119, 1653120, 1653122, 1653123, 1653124, 1653125, 1653127, 1653128, 1653130, 1820709, 1820710, 1820711, 1820712, 1820714, 1820715, 1820717, 1820718, 1820719, 1906327, 1906328, 1906329, 1906330, 1906331, 1906332, 1906333, 1906334, 1906335, 1906336, 1906338, 1924469, 1924470, 1924471, 1924472, 1924473, 1948966, 1948967, 1948968, 1948969, 1948970, 1948973, 1948974, 1948976, 1948977, 1948978, 1948979, 1948980, 1948981, 1948982, 1948983, 1948984, 1948985, 1948986, 2045947, 2045948, 2045950, 2045951, 2045952, 2045953, 2045954, 2045955, 2045956, 2045957, 2045958, 2045960, 2045961, 2045962, 2045963, 2045964, 2045965, 2045966, 2045967, 2045968, 2045969, 2045970, 2045971, 2045972, 2045973, 2045974, 2045975, 2045976, 2045977, 2045978, 2045979, 2092737, 2092738, 2092739, 2092740, 2092741, 2092742, 2092744, 2092746, 2092747, 2092748, 2150963, 2150964, 2150965, 2150966, 2150967, 2150968, 2150969, 2150970, 2150971, 2150972, 2167964, 2167965, 2167966, 2167967, 2167968, 2167969, 2167970, 2167971, 2167972, 2167973, 2167974, 2167975, 2167976, 2167977, 2167978, 2167979, 2167980, 2167981, 2167982, 2200417, 2200418, 2200419, 2200420, 2200421, 2200422, 2200423, 2200424, 2200425, 2200426, 2200428, 2200429, 2200430, 2200431, 2200432, 2200433, 2200434, 2239735, 2239736, 2239737, 2239738, 2239739, 2239740, 2239741, 2239742, 2278207, 2278209, 2278210, 2278211, 2278212, 2278213, 2278214, 2278215, 2278216, 2278217, 2278218, 2278219, 2324604, 2324605, 2324606, 2324607, 2324608, 2324609, 2324610, 2324611, 2324612, 2324614, 2324615, 2324616, 2381423, 2381424, 2381425, 2381426, 2381428, 2381429, 2381430, 2381431, 2381432, 2381433, 2381434, 2381435, 2381436, 2381437, 2381438, 2381439, 2381440, 2381441, 2381442, 2381443, 2381444, 2381445, 2381446, 2381447, 2381448, 2436991, 2436992, 2436993, 2436994, 2436995, 2436996, 2436997, 2436998, 2436999, 2437000, 2437001, 2437002, 2437003, 2437004, 2437005, 2437006, 2437007, 2437008, 2437009, 2437010, 2534578, 2534579, 2534581, 2534582, 2534583, 2534586, 2534587, 2534588, 2534589, 2534590, 2534591, 2534592, 2534594, 2576261, 2576262, 2576263, 2576264, 2576265, 2576266, 2576267, 2666487, 2666488, 2666489, 2666490, 2666491, 2666492, 2666493, 2666494, 2666496, 2666497, 2666498, 2666499, 2666500, 2666501, 2666502, 2666503, 2666504, 2666505, 2666506, 2666507, 2666508, 2666509, 2666511, 2666512, 2666513, 2775409, 2775410, 2775411, 2775412, 2775413, 2775414, 2775415, 2775416, 2775418, 2775420, 2775421, 2775422, 2878263, 2878264, 2878265, 2878266, 2878267, 2878268, 2878269, 2878270, 2878271, 2878272, 2878273, 2916962, 2916963, 2916964, 2916966, 2916967, 2916968, 2916969, 2916971, 2916972, 2916973, 2916974, 2916975, 2916976, 2916977, 2916978, 2976255, 2976256, 2976257, 2976258, 2976259, 2976260, 2976261, 2998473, 2998474, 2998475, 2998476, 2998477, 2998478, 2998479, 2998480, 2998481, 2998482, 2998484, 2998485, 2998486, 2998487, 2998488, 2998489, 2998490, 2998492, 2998493, 2998494, 2998495, 3631526, 3631527, 3631528, 3631529, 3631530, 3631531, 3631532, 3631533, 3631534, 3631535, 3631536, 3631537, 3631538, 3631539, 3631540, 3631541, 3631542, 3631543, 3631544, 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4861398, 4861399, 4861400, 4861401, 4861402, 4861403, 4861404, 4861405, 4861406, 4992726, 4992727, 4992728, 4992731, 4992733, 4992734, 4992735, 5140346, 5140347, 5140348, 5140349, 5140350, 5140351, 5140353, 5140354, 5140355, 5171907, 5171908, 5171909, 5171910, 5171911, 5171912, 5171913, 5171914, 5171915, 5171916, 5171917, 5171918, 5171919, 5171920, 5171921, 5171923, 5171924, 5171925, 5171927, 5171928, 5171929, 5171931, 5171932, 5356657, 5356658, 5356660, 5356661, 5356662, 5356663, 5356665, 5356666, 5356667, 5479538, 5479539, 5479540, 5479541, 5479542, 5479543, 5479544, 5479545, 5479546, 5479547, 5479548, 5479549, 5479550, 5479551, 5479553, 5479554, 5479555, 5479556, 5479557, 5479558, 5479559, 5479560, 5479561, 5479562, 5550272, 5550273, 5550274, 5550275, 5550276, 5550277, 5550278, 5550279, 5550280, 5550281, 5550282, 5550283, 5550284, 5550285, 5550286, 5550287, 5550288, 5550289, 5550294, 5550295, 5550296, 5550297, 5550298, 5630398, 5630400, 5630401, 5630402, 5630403, 5630404, 5630405, 5630407, 5630409, 5630410, 5630411, 5630412, 5630413, 5630414, 5630415, 5630416, 5630418, 5630419, 5630420, 5630421, 5630422, 5630423, 5992114, 5992115, 5992116, 5992118, 5992119, 5992120, 5992121, 5992122, 5992123, 5992125, 5992127, 5992128, 5992129, 5992130, 5992132, 5992134, 5992135, 5992138, 5992140, 5992141, 6638943, 6638944, 6638945, 6638946, 6638947, 6638948, 6638950, 6638951, 6638952, 6638954, 6638955, 6638956, 6638957, 6638959, 6638960, 6638961, 6638962, 6638966, 6638969, 7031973, 7031974, 7092067, 7092068, 7092071, 7092072, 7092073, 7092075, 7092076, 7092081, 7092082, 7092084, 7092085; c. REF 134-36-43, GUDID 10885862024022, Serial Numbers: 1152913, 1152914, 1152915, 1152916, 1152917, 1152918, 1152919, 1152921, 1152922, 1152923, 1152926, 1152927, 1152928, 1152929, 1152931, 1152932, 1334413, 1334414, 1334415, 1334416, 1334417, 1334418, 1334420, 1334421, 1334423, 1334424, 1334425, 1334427, 1334430, 1334432, 1396299, 1396301, 1396302, 1396303, 1396304, 1396305, 1396307, 1396309, 1396310, 1396312, 1396313, 1396314, 1396317, 1396318, 1396319, 1521910, 1521912, 1521913, 1521914, 1521916, 1521917, 1521918, 1521919, 1521920, 1521921, 1521922, 1605519, 1605520, 1605521, 1605522, 1605523, 1605524, 1605526, 1605527, 1655022, 1655024, 1655026, 1655028, 1655029, 1655030, 1655032, 1655033, 1655034, 1655035, 1655036, 1655037, 1655038, 1655039, 1655040, 1655041, 1655042, 1893502, 1893503, 1893504, 1893507, 1893508, 1893510, 1893512, 1893513, 1893514, 1893515, 1946913, 1946914, 1946915, 1946916, 1946917, 1987580, 1987581, 1987582, 1987583, 1987584, 1987585, 1987586, 1987587, 1987589, 1987590, 1987591, 1987592, 1987593, 1987594, 1987595, 1987596, 1987597, 1987598, 1987599, 1987600, 2005863, 2005864, 2005865, 2005866, 2005869, 2005870, 2005871, 2090722, 2090724, 2090725, 2090727, 2090728, 2090729, 2090731, 2090732, 2090733, 2090734, 2090735, 2090736, 2090737, 2168380, 2168381, 2168382, 2168383, 2168384, 2168385, 2168386, 2168387, 2168388, 2168389, 2168390, 2168391, 2168392, 2168393, 2168394, 2168396, 2168397, 2168398, 2168399, 2168400, 2168401, 2168402, 2168403, 2168404, 2168405, 2168406, 2168407, 2168408, 2168409, 2168410, 2375660, 2375662, 2375663, 2375664, 2375665, 2375666, 2375667, 2375668, 2375669, 2375670, 2375671, 2375672, 2375673, 2375674, 2375675, 2426888, 2426889, 2426890, 2426891, 2426892, 2426893, 2426894, 2426895, 2426896, 2426897, 2426899, 2426900, 2426901, 2426902, 2426903, 2426904, 2426905, 2426906, 2426907, 2426908, 2484250, 2484251, 2484252, 2484254, 2484255, 2484256, 2484259, 2484260, 2484261, 2484262, 2484263, 2484264, 2484265, 2484266, 2484267, 2484268, 2484269, 2484270, 2484271, 2484272, 2484273, 2484274, 2576270, 2576271, 2709176, 2778634, 2778635, 2778638, 2801748, 2801749, 2878178, 2878179, 2878180, 2878181, 2878182, 2878183, 2878184, 2878185, 2878186, 2878187, 2878188, 2980075, 2980076, 2980077, 2980078, 2980079, 2980081, 2980082, 2980084, 2980085, 2980086, 2980087, 2980088, 2980090, 2980091, 2980092, 2980093, 2980094, 2980095, 2980096, 2980097, 2980098, 2980099, 2980100, 3601763, 3601764, 3601765, 3601766, 3601767, 3601768, 3601769, 3601770, 3601771, 3601772, 3601773, 3601774, 3601775, 3601776, 3601777, 3601778, 3601779, 3601780, 3601781, 3601782, 3601783, 3601786, 3601787, 3692265, 3692266, 3692267, 3692268, 3692270, 3692271, 3692272, 3692273, 3692274, 3692275, 3692276, 3692277, 3692279, 3692280, 3692281, 3692282, 3692283, 3692284, 3778039, 3841749, 3841750, 3841751, 3841752, 3874856, 3874857, 3874858, 3874859, 3874860, 3874861, 3874862, 3874863, 3892593, 3892594, 3892595, 4045479, 4045480, 4045481, 4045482, 4045483, 4045484, 4045485, 4045486, 4045487, 4045488, 4045489, 4117302, 4117303, 4117304, 4117305, 4117306, 4117307, 4117308, 4117309, 4117312, 4117313, 4117316, 4117319, 4117323, 4117326, 4117327, 4384073, 4384074, 4384076, 4384077, 4384083, 4384085, 4384086, 4384087, 4384089, 4384091, 4384092, 4384093, 4384094, 4384095, 4384096, 4748152, 4748153, 4854767, 4854768, 4854769, 4854770, 4854771, 4854772, 4854773, 4854774, 4854775, 4854776, 4854777, 4854778, 4854779, 4854780, 4854781, 4854782, 4854783, 4854784, 4854785, 5002352, 5002353, 5002354, 5002356, 5002358, 5002359, 5002360, 5027374, 5027375, 5027376, 5027377, 5027378, 5027379, 5027380, 5027381, 5027382, 5027383, 5087825, 5087828, 5087829, 5087830, 5087831, 5087832, 5087833, 5087834, 5159603, 5159604, 5159605, 5159606, 5159608, 5159609, 5159610, 5159611, 5505042, 5505043, 5505046, 5505047, 5505048, 5505049, 5505050, 5505052, 5505053, 5505054, 5505055, 5505056, 5505057, 5505058, 5505060, 5505061, 5505062, 5505063, 5505065, 5505067, 5505068, 5505069, 5700295, 5700297, 5700298, 5700300, 5700304, 5700305, 5700306, 5700308, 5700309, 5700313, 6135317, 6135318, 6135319, 6135320, 6135324, 6135326, 6135328, 6135330, 6135332, 6135333, 6135339, 6135340, 6135341, 6135342, 6136243, 6136245, 6136246, 6136250, 6136251, 6136252, 6136254, 6136256, 6136258, 6136261, 6136264, 6136266, 6136267, 6136268; d. REF 134-36-44, GUDID 10885862024039, Serial Numbers: 1152727, 1152728, 1152729, 1152730, 1152731, 1152732, 1152735, 1152736, 1152737, 1152739, 1152740, 1152742, 1152745, 1152746, 1338518, 1338519, 1338520, 1338522, 1338523, 1338524, 1338525, 1338526, 1338527, 1338530, 1338531, 1338532, 1338533, 1338534, 1338535, 1338536, 1338537, 1338538, 1516138, 1520744, 1520745, 1520749, 1520750, 1520751, 1520754, 1793730, 1793731, 1793732, 1793734, 1793735, 1793736, 1822158, 1822159, 1822160, 1822161, 1822162, 1822163, 1822166, 1844081, 1844083, 1844085, 1844086, 1844087, 1844088, 1844089, 1924327, 1924328, 1924331, 1924332, 1924333, 1924334, 1924335, 2078533, 2078534, 2152495, 2152496, 2152497, 2155194, 2155196, 2155197, 2155198, 2155200, 2155202, 2155204, 2155205, 2155206, 2155207, 2191334, 2191335, 2191336, 2191338, 2191339, 2191340, 2191341, 2191342, 2191343, 2191344, 2191346, 2407773, 2407774, 2407775, 2407776, 2407777, 2407778, 2407779, 2407780, 2481273, 2481274, 2481276, 2481278, 2481279, 2481281, 2481282, 2576273, 2594884, 2594885, 2594887, 2594891, 2594895, 2594896, 2594897, 2594898, 2594899, 2594900, 2594901, 2594902, 2594903, 2594904, 2594906, 2594907, 2594910, 2594913, 2594916, 2594917, 2594918, 2594920, 2986035, 2986036, 2986038, 2986039, 2986040, 2986041, 2986043, 2986044, 2986045, 2986046, 2986048, 2986049, 2986050, 2986051, 2986052, 2986053, 2986054, 2986056, 2986057, 2986059, 2986060, 2986061, 3683430, 3683432, 3683433, 3683435, 3683437, 3683438, 3683440, 3683441, 3683442, 3683443, 3683444, 3683445, 3683446, 3683447, 4076513, 4076514, 4076515, 4076517, 4076518, 4076519, 4076521, 4076522, 4076525, 4076530, 4076531, 4076534, 4076535, 4076538, 4076539, 4076540, 4215024, 4215025, 4215027, 4215035, 4751282, 4751283, 4751284, 4751285, 4751286, 4861627, 4861629, 4861632, 4861634, 5272148, 5272149, 5272152, 5303301, 5303303, 5381552, 5381558, 5381560, 5580111, 5580112, 5580113, 5580114, 5580115, 5866595, 5866597, 5866598, 6259942, 6259945, 6498857, 6498860, 6498861, 6498864, 6498865; e. REF 134-36-45, GUDID 10885862024046, Serial Numbers: 1152771, 1152772, 1152773, 1152778, 1152779, 1152780, 1152782, 1152784, 1338607, 1338608, 1338616, 1338617, 1338621, 1338624, 1338626, 1522159, 1522160, 1522162, 1641855, 1641858, 1641860, 1641864, 1641865, 1641867, 1641868, 1641869, 2006195, 2006196, 2006197, 2010909, 2010911, 2010913, 2010915, 2010920, 2010921, 2481293, 2677743, 2778776, 2800313, 2976244, 2976245, 2976246, 2976247, 2976248, 2976249, 2976251, 2976252, 2976253, 3768216, 3768219, 3768225, 3768229, 4137300, 4137314, 4137316, 4622463;

Quantity Affected: 2319 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