GXL acetabular liners recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a. REF 144-28-05, GUIDID 10885862027405, Serial Numbers: 646995, 646996, 646997, 646998, 667989, 667990, 667992, 667995, 667996, 668002, 668003, 668004, 770434, 770436, 770440, 770442, 770443, 770444, 863939, 863940, 863943, 863944, 863946, 863948, 1242282, 1242283, 1242284, 1242286, 1242287, 1242288, 1242290, 1242291, 1242292, 1617713, 1617715, 1617717, 1617718, 1617719, 1617720, 1617721, 1869774, 1869775, 1869776, 1869777, 1907611, 1907612, 1907613, 1907614, 1961038, 1961039, 1961040, 1961041, 1961042, 2019292, 2019293, 2019294, 2019295, 2174511, 2174512, 2175232, 2314993, 2314995, 2681417, 2681418, 2681428,; b. REF 144-28-06, GUIDID 10885862027412, Serial Numbers: 647081, 647082, 647083, 647084, 647085, 656277, 656278, 656279, 656281, 667456, 667459, 667466, 667467, 667468, 667470, 667471, 667472, 667474, 667475, 667476, 667477, 736674, 736675, 736677, 736678, 736684, 736685, 736687, 736688, 736689, 736691, 736692, 736695, 736697, 736698, 736704, 736705, 736706, 736707, 736710, 736711, 736712, 736716, 736720, 736722, 1088581, 1088582, 1088583, 1088585, 1088586, 1088587, 1088588, 1088589, 1088590, 1088592, 1088593, 1088594, 1088595, 1088596, 1088597, 1088598, 1088599, 1088601, 1088602, 1088604, 1088605, 1088606, 1088607, 1088608, 1088609, 1088611, 1088612, 1088614, 1088615, 1088616, 1088618, 1088619, 1503039, 1503040, 1503041, 1503043, 1613417, 1613418, 1613419, 1613420, 1613421, 1613422, 1613424, 1613425, 1613426, 1613427, 1748075, 1748076, 1748078, 1748082, 1779388, 1779389, 1779390, 1779391, 1779392, 1779393, 1779394, 1779395, 1779396, 1779397, 1869559, 1869560, 1869561, 1869562, 1869563, 1869564, 1869565, 1869566, 1869567, 1869568, 1869569, 1919876, 1919877, 1919878, 1919879, 1919880, 1958258, 1958259, 1958260, 1958261, 1958262, 1961605, 1961606, 1961607, 1961608, 1961609, 1961610, 1961611, 1961612, 1961613, 1961614, 1961615, 2057734, 2057735, 2057736, 2057737, 2057738, 2057739, 2071335, 2076278, 2102297, 2102298, 2127781, 2127782, 2154421, 2154422, 2154423, 2242513, 2242514, 2242516, 2332952, 2418182, 2418183, 2418185, 2418186, 2418187, 2418189, 2418190, 2681365, 2681366, 2681367, 2681370, 2681371, 2681374, 2681375, 2681378, 2681379, 2681381, 2681384, 2681386, 2681389, 2681391, 5434157, 5448537, 5479670,; c. REF 144-28-07, GUIDID 10885862027429, Serial Numbers: 656453, 656454, 656455, 656456, 667163, 667167, 667173, 667177, 667178, 667179, 667181, 667182, 667184, 667186, 667187, 735322, 735323, 735325, 735326, 735327, 735329, 735330, 735331, 735332, 735334, 735335, 735337, 735339, 735340, 735341, 735342, 735344, 735345, 735346, 735347, 1255739, 1255740, 1255741, 1255742, 1255743, 1255744, 1255745, 1255746, 1255747, 1255748, 1255749, 1255750, 1255751, 1255752, 1255753, 1255754, 1539344, 1539346, 1539347, 1539348, 1552589, 1552590, 1631561, 1631562, 1631563, 1631564, 1631565, 1631566, 1631567, 1631568, 1631570, 1631571, 1631573, 1631574, 1631575, 1631576, 1631578, 1631579, 1631580, 1848625, 1848627, 1848628, 1848629, 1848630, 1848631, 1848632, 1848633, 1848634, 1848635, 1848636, 1848637, 1848638, 1848639, 1848640, 1848641, 1848642, 1848643, 1848644, 1848645, 1995515, 1995516, 1995517, 1995518, 1999705, 2008666, 2020951, 2020952, 2076037, 2116750, 2154208, 2180270, 2180272, 2180273, 2180274, 2180275, 2314476, 2314478, 2314481, 2314482, 2314483, 2681343, 2681346, 2681362, 2681363, 2681364, 5620814; d. REF 144-28-08, GUIDID 10885862027436, Serial Numbers: 646958, 656496, 667567, 667571, 667575, 667578, 667581, 735816, 735818, 735819, 735821, 735822, 735824, 735825, 735826, 735829, 735831, 735832, 735833, 735835, 735836, 735838, 735839, 735841, 735842, 1496501, 1496502, 1496503, 1496504, 1496505, 1497983, 1497985, 1497986, 1628671, 1628672, 1628673, 1628676, 1628680, 1628681, 1780295, 1780296, 1780297, 1780298, 1780299, 1780300, 1780301, 1780302, 1780303, 1780304, 1886863, 1886865, 1886866, 1886867, 1886869, 1886870, 1886871, 1886872, 1886873, 1978121, 1978122, 1978123, 1978124, 1978125, 1978126, 1978127, 1978128, 1978129, 1978130, 1978131, 2154167, 2154169, 2155086, 2155088, 2173630, 2173632, 2173636, 2173637, 2203733, 2203735, 2203736, 2203737, 2675713, 2741976, 2741978, 2741979, 2741980, 3877265, 3877269,; e. REF 144-28-09, GUIDID 10885862027443, Serial Numbers: 646927, 646928, 656808, 667271, 667274, 667278, 667280, 667286, 735649, 735650, 735652, 735657, 735658, 735659, 735660, 735661, 735663, 735665, 735667, 1501517, 1501518, 1501519, 1619068, 1619071, 1758479, 1758480, 1758482, 1758483, 1758484, 1758485, 1758487, 1758488, 1907668, 1907669, 1907670, 1907671, 1907673, 1907674, 1907675, 1907676, 2015630, 2015631, 2015632, 2015633, 2173625, 2173626, 2173627, 2173628, 2173629, 2315681, 2315686, 2315688, 2681432, 2681433, 2681435, 2681436, 2681438, 2681444, 2681449, 5448848; f. REF 144-28-10, GUIDID 10885862027450, Serial Numbers: 732949, 732957, 732958, 1501571, 1626559, 1626560, 1626564, 1766032, 1766033, 1766034, 1766036, 1766037, 1766038, 1766039, 1813495, 2314200, 2314201, 2522283, 2522284, 2675864, 2675866, 2675867, 2741969, 2741971, 2741972, 2741973; g. REF 146-28-04, GUIDID 10885862027719, Serial Numbers: 673521, 673522, 673523, 673524, 673526, 673527, 673528, 673529, 1071025, 1071031, 1071036, 1071037, 1071040, 2430266, 5092898, 5092901, 5987556; h. REF 146-28-05, GUIDID 10885862027726, Serial Numbers: 672814, 672817, 672821, 672822, 672823, 672824, 672825, 672828, 672831, 672832, 1440928, 1440929, 1440930, 1440932, 1597246, 3645387, 3731190; i. REF 146-32-06, GUIDID 10885862027771, Serial Numbers: 652352, 652353, 652355, 652359, 652364, 786425, 786432, 786438, 786447, 786456, 1501636, 1501638, 1501639, 1501640, 1788763, 1902369, 1902370, 1902371, 1902372, 1902373, 1939712, 1939713, 1939714, 1939715, 1939716, 2155789, 2205295, 2205296, 2205297, 2205298, 2205299, 2205300, 2205301, 2205302, 2205303, 2591479, 2591480, 2744018, 2744019, 2744020, 2744021, 2744022, 2744023, 2833717, 2833718, 2833719, 2833720, 2833721, 2853034, 2853035, 2853036, 2853037, 2853038, 2853039, 2853040, 2853041, 2853042, 2853043, 2853044, 2853045, 2960474, 2960476, 2960477, 2998200, 2998201, 2998202, 4116872, 4125594, 4125599, 4125600, 5983742, 6616862; j. REF 144-32-05, GUIDID 10885862027467, Serial Numbers: 667367, 750499, 750500, 750510, 750511, 1466301, 1468509, 1468510, 1760868, 1760869, 1760870, 1760871, 1760872, 1761157, 2014622, 2116742, 2178819, 2178820, 2178821, 2178822, 2408155, 2408156, 2408157, 2408158, 2408159, 2408160, 2408161, 3877259, 3952744, 4040044, 4040046; k. REF 144-32-06, GUIDID 10885862027474, Serial Numbers: 652352, 652353, 652355, 652359, 652364, 786425, 786432, 786438, 786447, 786456, 1501636, 1501638, 1501639, 1501640, 1788763, 1902369, 1902370, 1902371, 1902372, 1902373, 1939712, 1939713, 1939714, 1939715, 1939716, 2155789, 2205295, 2205296, 2205297, 2205298, 2205299, 2205300, 2205301, 2205302, 2205303, 2591479, 2591480, 2744018, 2744019, 2744020, 2744021, 2744022, 2744023, 2833717, 2833718, 2833719, 2833720, 2833721, 2853034, 2853035, 2853036, 2853037, 2853038, 2853039, 2853040, 2853041, 2853042, 2853043, 2853044, 2853045, 2960474, 2960476, 2960477, 2998200, 2998201, 2998202, 4116872, 4125594, 4125599, 4125600, 5983742, 6616862; l. REF 144-32-07, GUIDID 10885862027481, Serial Numbers: 646979, 646980, 646981, 646982, 656282, 656283, 656285, 667544, 667545, 667547, 667548, 667549, 667550, 667551, 667552, 667553, 667555, 667557, 667558, 667559, 667560, 667561, 667562, 667563, 733057, 733058, 733059, 733060, 733061, 733062, 733063, 733065, 733067, 733068, 733069, 733070, 733071, 733072, 733073, 733074, 733075, 733076, 733077, 733079, 733080, 733081, 733082, 733083, 733084, 733085, 733086, 733087, 1083038, 1083039, 1083041, 1083043, 1083044, 1083045, 1083046, 1083047, 1083048, 1083049, 1083050, 1083051, 1083052, 1083053, 1240363, 1240364, 1240365, 1240366, 1240367, 1240368, 1240369, 1240370, 1240371, 1240372, 1240373, 1637247, 1637248, 1637249, 1637250, 1637251, 1637252, 1637253, 1637255, 1637256, 1960914, 1960915, 1960916, 1960917, 1960918, 1978108, 1978109, 1978110, 1978111, 1978112, 2199477, 2199478, 2199479, 2199480, 2199481, 2209286, 2209287, 2209288, 2209289, 2209290, 2316057, 2316058, 2316060, 2316061, 2316062, 2316063, 2316065, 2316066, 2534039, 2534040, 2534042, 2534043, 2534044, 2534045, 2534046, 2534047, 2709177, 2741974, 2741975, 2760031, 2825163, 2998199, 3695205, 4033071, 4057982, 4057983, 4057984, 4057985, 4057986, 4269948, 4269949, 4269950, 4269953, 4269954, 4269955, 4269959, 4269960, 4269961, 4269963, 4269964, 4269965, 4269966, 6035701, 6035704; m. REF 144-32-08, GUIDID 10885862027498, Serial Numbers: 646984, 646985, 646987, 646988, 656490, 656491, 656492, 656493, 656494, 667530, 667531, 667533, 667534, 667535, 667536, 667537, 667538, 667539, 667542, 667543, 733870, 733872, 733873, 733874, 733875, 733877, 733879, 733881, 733882, 733883, 733884, 733887, 733888, 733889, 733891, 733892, 733893, 733894, 733895, 1099238, 1099239, 1099241, 1099242, 1099243, 1099246, 1099247, 1099248, 1597853, 1597854, 1597855, 1613660, 1613662, 1613663, 1821432, 1821433, 1821434, 1821435, 1821436, 1821437, 1821438, 2315089, 2315090, 2400213, 2400214, 2400215, 2400216, 2400217, 2400218, 2400219, 2795185, 2795186, 2795188, 2795192, 2795193, 2795194, 2795197, 2795198, 2795199, 2795200, 2795201, 2795202, 2795204, 2795209, 5448809, 5448810, 5448811, 5501762; m. REF 144-32-09, GUIDID 10885862027504, Serial Numbers: 646970, 646971, 646972, 656764, 656765, 656767, 656768, 667686, 667687, 667689, 667690, 667691, 667695, 732988, 732989, 732991, 732992, 732993, 732995, 732997, 732998, 732999, 733000, 733002, 733004, 733006, 733009, 733010, 733011, 1098128, 1098130, 1098131, 1098132, 1098133, 1098135, 1098137, 1758159, 1758161, 1758163, 1758164, 1758165, 1758166, 1995520, 1995522, 1995523, 1995524, 2205545, 2205546, 2205547, 2316311, 2400723, 2408785, 2484275, 2505368, 2505369, 2505370, 2505371, 2533442, 2675868, 2675869, 2675870, 2675871, 2675872, 2675873, 4061421, 4061422, 4249796, 4249803, 5577615; o. REF 144-32-10, GUIDID 10885862027511, Serial Numbers: 646959, 667640, 733100, 733108, 1501641, 1700462, 1758490, 1836563, 1836564, 1836565, 1836567, 1836568, 1836569, 1836570, 1836571, 1836572, 2199475, 2199476, 2314645, 2314646, 2400076, 2400077, 2400078, 4040047.

Product

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;

Recalling firm

Exactech, Inc.

Quantity

1017 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

Recall date

September 21, 2022

Classification

Class II

Status

Ongoing

Agency

FDA (device)