GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER S

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. 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;

Lot/Code Info: 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.

Quantity Affected: 1017 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