—#194020

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;

FDA product code: KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040601
Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

Timeline

Recall initiated: 2022-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.