Exactech Equinoxe Glenoid (Exactech) – Packaging Nonconformance (2024)
Non-standard packaging can potentially compromise medical implant sterility.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
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According to the U.S. Food and Drug Administration (FDA)
Product
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
a) Item Number 314-02-22, UDI/DI 10885862175052, Serial Numbers: 1984576, 1984575, 2090821, 1984570, 1984581, 1984569, 2090824, 2093611, 2090832, 2090825, 2379003, 2090861, 2090820, 1984577, 2090843, 2378999, 2379029, 2425682, 2378998, 2090854, 2425684, 2093636, 2090855, 2093634, 2425676, 1984573, 2485867, 2379017, 2090842, 2640254, 2640262, 2640255, 2754817, 2093618, 2379019, 2090826, 2640241, 2654891, 2093613, 2093621, 2654890, 2485860, 2425689, 2090863, 2425683, 2654887, 2628323, 2640277, 2951278, 2961486, 2090862, 2090850, 2640252, 2640279, 2654888, 2654892, 2654894, 2379025, 2640261, 2754818, 3600551, 3600548, 3600552, 3600562, 3600553, 3600561, 3600565, 3600560, 3600550, 3600559, 2090852, 2654893, 2425667, 2145999, 2425669, 2594873, 2640268, 2628315, 2640280, 2754815, 2983602, 4523829, 4523835, 3936374, 3570106, 3570101, 3570098, 3936367, 2640271, 3941936, 3600547, 4431925, 4987572, 4987573, 4925598, 2640257, 4497767, 3600546, 3936376, 3600556, 4459029, 3570097, 4459036, 5304678, 5404184, 5304679, 5320000, 5061891, 4651003, 4780605, 4475610, 4485961, 4485962, 5159660, 5540792, 5540797, 5320009, 5404188, 4666781, 5304682, 5319984, 5883347, 5883348, 5929682, 5929698, 5929699, 5883346, 5883355, 5883354, 5883340, 5883335, 5540799, 5404170, 5304686, 5304681, 5883344, 5929692, 4459042, 5320016, 4780611, 5540804, 5404178, 5929691, 6847326, 6847328, 6847320, 6847321, 6847332, 5929703, 5929684, 5159648, 5404185, 5304675, 5304710, 5404171, 4917534, 6847341, 6847323, 6847336, 5929687, 5883339, 7034749, 7034750, 7034755, 7034756, 7034759, 7034751, 6847334, 6190062, 6847333, b) Item Number 314-02-23, UDI/DI 10885862175069, Serial Numbers: 1984153, 1984161, 2093802, 2093792, 2067826, 1984166, 2067811, 1984159, 2067793, 2067816, 2150615, 2067802, 2093779, 2426046, 2150607, 2150602, 1984163, 2067809, 2093772, 2067813, 1984168, 2426089, 2093783, 2067822, 2067803, 2426036, 1984167, 2093788, 2067835, 1984154, 1984160, 2150631, 2067815, 2067789, 2093764, 2093773, 2093805, 2426084, 2093780, 2093799, 2426065, 2479772, 2559240, 2067831, 2479781, 2093778, 2426047, 2426082, 2426061, 2426057, 2479771, 2150627, 2067797, 2093765, 2479764, 1984169, 2426088, 2559239, 2093789, 2093793, 2093768, 2093810, 2479776, 2426041, 2591548, 2628326, 2426045, 2640307, 2640293, 2747836, 2747853, 2067790, 2559246, 2426060, 1984165, 2150617, 2067808, 2150638, 2067791, 2067796, 2067810, 2150616, 2067786, 2426049, 2067829, 1984156, 2559243, 2559247, 2559250, 2640315, 2067800, 2559252, 2067801, 2426058, 2093785, 2479779, 2479768, 2426076, 2426080, 2067818, 2628329, 2426063, 2628327, 2747842, 2942478, 2747843, 3570244, 2942482, 3570242, 2942481, 3570226, 2976331, 2747850, 3570245, 2976334, 3570234, 2747851, 3570223, 2976335, 2067833, 2150620, 2479780, 2426087, 2093776, 2067806, 2640290, 2426052, 2426053, 2150628, 2150640, 2426079, 2150600, 2067792, 2479766, 2093794, 2067834, 2093774, 2093800, 2093813, 2640311, 2559245, 2093786, 2067812, 2640312, 2640319, 2628330, 2640294, 2747854, 3759705, 2976336, 3896104, 2942496, 2747839, 3759697, 3759692, 2942494, 2942483, 3759698, 3759689, 3759694, 3759696, 3759703, 3759706, 3759707, 3825275, 3825282, 3600585, 3600580, 3600581, 2150635, 2479774, 2150603, 2479765, 2640302, 2067823, 2640308, 2150629, 2628325, 2942490, 3825272, 2747841, 3896091, 2942492, 3896120, 3570225, 2942476, 3570229, 4512379, 3896122, 3600577, 3896114, 3600568, 4398412, 4512381, 3600571, 3570235, 2628328, 4398425, 4475599, 4512377, 2942493, 3896124, 3825280, 3570240, 4520235, 3600567, 3600572, 3600575, 3570228, 4398429, 3600569, 3896116, 3896121, 3825274, 3896111, 4780792, 4780793, 3825283, 3570239, 3925787, 3825284, 3896113, 3759693, 3925783, 5076184, 5139193, 5351490, 4780789, 4587489, 5076182, 5291504, 5599689, 5599680, 5599693, 5599697, 3570231, 4523839, 3896103, 5291510, 5159878, 5291501, 4587485, 5866689, 5866684, 5599683, 5866680, 5866688, 5866690, 5866685, 5599687, 5599681, 5578263, 5599672, 5929665, 5599688, 3896112, 4398421, 4780784, 4780787, 4780786, 6135397, 5929672, 6135422, 5929653, 6135403, 6135399, 5929667, 4523840, 5351476, 5428701, 5428675, 5139195, 5076181, 5291522, 5291499, 5929674, 6576862, 6839511, 5929651, 6839502, 6576860, 6839534, 6839536, 6135418, 6576847, 6576857, 6839500, 5599692, 6849234, 5428689, 5291506, 5291520, 5291498, 5428674, 5351478, 5351482, 5578267, 6839538, 6839501, 5929660, 5747339, 5599669, 6576850, 6576866, 5929654, 6839516, 5929659, 5866682, 6135413, 6576855, 5929652, 6135416, 5599679, 6839539, 5599691, 6576852, 6849248, 6135410, 5599668, 6849235, 5747356, 5599700, c) Item Number 314-02-24, UDI/DI 10885862175076, Serial Numbers: 1984246, 2073722, 1984239, 1984245, 2073700, 1984236, 2073696, 2073694, 1984241, 1984248, 2094924, 2073690, 2094918, 2094908, 2485852, 2094929, 2094903, 2146925, 2073728, 2073692, 1984242, 1984250, 2073727, 1984243, 2094935, 2094891, 2094920, 2094910, 2427421, 2073684, 2146930, 2413530, 2413532, 2413541, 2413516, 2413539, 2485857, 2413544, 2485854, 2073683, 2146929, 2427413, 2637799, 2413517, 2621366, 2637785, 2073707, 2094893, 2485843, 2485845, 2637776, 1984249, 2073724, 2073686, 2637805, 1984244, 2427412, 2413509, 2073719, 2413520, 2485842, 2073714, 2094897, 2073688, 2413518, 2637807, 2485851, 2094923, 2637771, 2146918, 2413553, 2427415, 2413491, 2413502, 2594881, 2752416, 2637782, 2146917, 2637763, 2637778, 2094904, 2094926, 2146932, 2427417, 2413555, 2094911, 2413536, 2637768, 2637777, 2073731, 2094934, 2413494, 2146921, 2427414, 2413558, 2094892, 2073713, 2073725, 2637797, 2073687, 2752403, 2877181, 2752412, 2942509, 2942514, 2752417, 2942512, 2877182, 2752407, 2752408, 2413551, 2073699, 2094922, 2073721, 2073704, 2413514, 2621367, 2413501, 2637803, 2637787, 2637796, 2094927, 2413508, 2413490, 2637775, 2413499, 2073709, 2073732, 1984240, 2583785, 2942516, 2877177, 3574668, 2961490, 2752411, 3574654, 3825267, 2877179, 2961494, 3574644, 2942497, 3574641, 3951688, 3574645, 3574647, 3574652, 3574659, 3574661, 3574669, 3574653, 3574658, 3574649, 2621365, 2073691, 2413545, 2146920, 2413548, 2485855, 2637794, 3574665, 3574646, 2961487, 3951686, 4122915, 3825264, 4475631, 4523817, 4122898, 2961489, 4122892, 4122919, 2413533, 2637774, 2637773, 2594879, 2621369, 2637795, 3825258, 4454025, 2752414, 3936360, 4454020, 4122906, 4122893, 3825262, 2637801, 3825270, 4122918, 4475633, 3574670, 5318756, 4587407, 5103433, 5561023, 5561025, 5561002, 3825261, 4122902, 3936362, 3936359, 3936364, 4122907, 4790524, 5316541, 5538731, 5318765, 5929367, 5717019, 5833709, 6222491, 6222495, 6218718, 6218730, 6218733, 6218731, 5833719, 5561024, 4523819, 5318759, 5929361, 6222500, 6222509, 6222502, 5717012, 4790527, 5061884, 4951247, 5316550, 5538723, 5318764, 5103432, 4684863, 5318760, 4790525, 5538729, 6218719, 6847302, 5833716, 6222507, 6223922, 5561003, 6824907, 6847306, 5929353, 5561013, 5179799, 5061879, 5316535, 5717020, 6222496, 5561018, 6222506, 6824899, 6824888, 6824894, 5561008, 5929360, 5561004, 5929345, 6222499, 6847289, 6218740, 5929350, 6222487, 6218724, 6222486, 5929354, 5717011, 6218720, 5929358, 5717024, d) Item Number 314-02-25, UDI/DI 10885862175083, Serial Numbers: 1984594, 1984595, 1984596, 1984593, 2086796, 2147635, 2485875, 2637753, 2167696, 2147618, 2147649, 2419041, 2147644, 2142520, 3592854, 3571536, 2591549, 4555103, 4521883, 4925728, 4148695, 4607449, 5163430, 4572652, 4521882, 5543395, 4607452, 5319922, 5543410, 5543408, 5319946, 5960413, 5381658, 5960424, 4607451, 6872159, 4925733, 5319919, 5319942, 5381668, 5163412, 5960410
Products Sold
a) Item Number 314-02-22, UDI/DI 10885862175052, Serial Numbers: 1984576, 1984575, 2090821, 1984570, 1984581, 1984569, 2090824, 2093611, 2090832, 2090825, 2379003, 2090861, 2090820, 1984577, 2090843, 2378999, 2379029, 2425682, 2378998, 2090854, 2425684, 2093636, 2090855, 2093634, 2425676, 1984573, 2485867, 2379017, 2090842, 2640254, 2640262, 2640255, 2754817, 2093618, 2379019, 2090826, 2640241, 2654891, 2093613, 2093621, 2654890, 2485860, 2425689, 2090863, 2425683, 2654887, 2628323, 2640277, 2951278, 2961486, 2090862, 2090850, 2640252, 2640279, 2654888, 2654892, 2654894, 2379025, 2640261, 2754818, 3600551, 3600548, 3600552, 3600562, 3600553, 3600561, 3600565, 3600560, 3600550, 3600559, 2090852, 2654893, 2425667, 2145999, 2425669, 2594873, 2640268, 2628315, 2640280, 2754815, 2983602, 4523829, 4523835, 3936374, 3570106, 3570101, 3570098, 3936367, 2640271, 3941936, 3600547, 4431925, 4987572, 4987573, 4925598, 2640257, 4497767, 3600546, 3936376, 3600556, 4459029, 3570097, 4459036, 5304678, 5404184, 5304679, 5320000, 5061891, 4651003, 4780605, 4475610, 4485961, 4485962, 5159660, 5540792, 5540797, 5320009, 5404188, 4666781, 5304682, 5319984, 5883347, 5883348, 5929682, 5929698, 5929699, 5883346, 5883355, 5883354, 5883340, 5883335, 5540799, 5404170, 5304686, 5304681, 5883344, 5929692, 4459042, 5320016, 4780611, 5540804, 5404178, 5929691, 6847326, 6847328, 6847320, 6847321, 6847332, 5929703, 5929684, 5159648, 5404185, 5304675, 5304710, 5404171, 4917534, 6847341, 6847323, 6847336, 5929687, 5883339, 7034749, 7034750, 7034755, 7034756, 7034759, 7034751, 6847334, 6190062, 6847333; b) Item Number 314-02-23, UDI/DI 10885862175069, Serial Numbers: 1984153, 1984161, 2093802, 2093792, 2067826, 1984166, 2067811, 1984159, 2067793, 2067816, 2150615, 2067802, 2093779, 2426046, 2150607, 2150602, 1984163, 2067809, 2093772, 2067813, 1984168, 2426089, 2093783, 2067822, 2067803, 2426036, 1984167, 2093788, 2067835, 1984154, 1984160, 2150631, 2067815, 2067789, 2093764, 2093773, 2093805, 2426084, 2093780, 2093799, 2426065, 2479772, 2559240, 2067831, 2479781, 2093778, 2426047, 2426082, 2426061, 2426057, 2479771, 2150627, 2067797, 2093765, 2479764, 1984169, 2426088, 2559239, 2093789, 2093793, 2093768, 2093810, 2479776, 2426041, 2591548, 2628326, 2426045, 2640307, 2640293, 2747836, 2747853, 2067790, 2559246, 2426060, 1984165, 2150617, 2067808, 2150638, 2067791, 2067796, 2067810, 2150616, 2067786, 2426049, 2067829, 1984156, 2559243, 2559247, 2559250, 2640315, 2067800, 2559252, 2067801, 2426058, 2093785, 2479779, 2479768, 2426076, 2426080, 2067818, 2628329, 2426063, 2628327, 2747842, 2942478, 2747843, 3570244, 2942482, 3570242, 2942481, 3570226, 2976331, 2747850, 3570245, 2976334, 3570234, 2747851, 3570223, 2976335, 2067833, 2150620, 2479780, 2426087, 2093776, 2067806, 2640290, 2426052, 2426053, 2150628, 2150640, 2426079, 2150600, 2067792, 2479766, 2093794, 2067834, 2093774, 2093800, 2093813, 2640311, 2559245, 2093786, 2067812, 2640312, 2640319, 2628330, 2640294, 2747854, 3759705, 2976336, 3896104, 2942496, 2747839, 3759697, 3759692, 2942494, 2942483, 3759698, 3759689, 3759694, 3759696, 3759703, 3759706, 3759707, 3825275, 3825282, 3600585, 3600580, 3600581, 2150635, 2479774, 2150603, 2479765, 2640302, 2067823, 2640308, 2150629, 2628325, 2942490, 3825272, 2747841, 3896091, 2942492, 3896120, 3570225, 2942476, 3570229, 4512379, 3896122, 3600577, 3896114, 3600568, 4398412, 4512381, 3600571, 3570235, 2628328, 4398425, 4475599, 4512377, 2942493, 3896124, 3825280, 3570240, 4520235, 3600567, 3600572, 3600575, 3570228, 4398429, 3600569, 3896116, 3896121, 3825274, 3896111, 4780792, 4780793, 3825283, 3570239, 3925787, 3825284, 3896113, 3759693, 3925783, 5076184, 5139193, 5351490, 4780789, 4587489, 5076182, 5291504, 5599689, 5599680, 5599693, 5599697, 3570231, 4523839, 3896103, 5291510, 5159878, 5291501, 4587485, 5866689, 5866684, 5599683, 5866680, 5866688, 5866690, 5866685, 5599687, 5599681, 5578263, 5599672, 5929665, 5599688, 3896112, 4398421, 4780784, 4780787, 4780786, 6135397, 5929672, 6135422, 5929653, 6135403, 6135399, 5929667, 4523840, 5351476, 5428701, 5428675, 5139195, 5076181, 5291522, 5291499, 5929674, 6576862, 6839511, 5929651, 6839502, 6576860, 6839534, 6839536, 6135418, 6576847, 6576857, 6839500, 5599692, 6849234, 5428689, 5291506, 5291520, 5291498, 5428674, 5351478, 5351482, 5578267, 6839538, 6839501, 5929660, 5747339, 5599669, 6576850, 6576866, 5929654, 6839516, 5929659, 5866682, 6135413, 6576855, 5929652, 6135416, 5599679, 6839539, 5599691, 6576852, 6849248, 6135410, 5599668, 6849235, 5747356, 5599700; c) Item Number 314-02-24, UDI/DI 10885862175076, Serial Numbers: 1984246, 2073722, 1984239, 1984245, 2073700, 1984236, 2073696, 2073694, 1984241, 1984248, 2094924, 2073690, 2094918, 2094908, 2485852, 2094929, 2094903, 2146925, 2073728, 2073692, 1984242, 1984250, 2073727, 1984243, 2094935, 2094891, 2094920, 2094910, 2427421, 2073684, 2146930, 2413530, 2413532, 2413541, 2413516, 2413539, 2485857, 2413544, 2485854, 2073683, 2146929, 2427413, 2637799, 2413517, 2621366, 2637785, 2073707, 2094893, 2485843, 2485845, 2637776, 1984249, 2073724, 2073686, 2637805, 1984244, 2427412, 2413509, 2073719, 2413520, 2485842, 2073714, 2094897, 2073688, 2413518, 2637807, 2485851, 2094923, 2637771, 2146918, 2413553, 2427415, 2413491, 2413502, 2594881, 2752416, 2637782, 2146917, 2637763, 2637778, 2094904, 2094926, 2146932, 2427417, 2413555, 2094911, 2413536, 2637768, 2637777, 2073731, 2094934, 2413494, 2146921, 2427414, 2413558, 2094892, 2073713, 2073725, 2637797, 2073687, 2752403, 2877181, 2752412, 2942509, 2942514, 2752417, 2942512, 2877182, 2752407, 2752408, 2413551, 2073699, 2094922, 2073721, 2073704, 2413514, 2621367, 2413501, 2637803, 2637787, 2637796, 2094927, 2413508, 2413490, 2637775, 2413499, 2073709, 2073732, 1984240, 2583785, 2942516, 2877177, 3574668, 2961490, 2752411, 3574654, 3825267, 2877179, 2961494, 3574644, 2942497, 3574641, 3951688, 3574645, 3574647, 3574652, 3574659, 3574661, 3574669, 3574653, 3574658, 3574649, 2621365, 2073691, 2413545, 2146920, 2413548, 2485855, 2637794, 3574665, 3574646, 2961487, 3951686, 4122915, 3825264, 4475631, 4523817, 4122898, 2961489, 4122892, 4122919, 2413533, 2637774, 2637773, 2594879, 2621369, 2637795, 3825258, 4454025, 2752414, 3936360, 4454020, 4122906, 4122893, 3825262, 2637801, 3825270, 4122918, 4475633, 3574670, 5318756, 4587407, 5103433, 5561023, 5561025, 5561002, 3825261, 4122902, 3936362, 3936359, 3936364, 4122907, 4790524, 5316541, 5538731, 5318765, 5929367, 5717019, 5833709, 6222491, 6222495, 6218718, 6218730, 6218733, 6218731, 5833719, 5561024, 4523819, 5318759, 5929361, 6222500, 6222509, 6222502, 5717012, 4790527, 5061884, 4951247, 5316550, 5538723, 5318764, 5103432, 4684863, 5318760, 4790525, 5538729, 6218719, 6847302, 5833716, 6222507, 6223922, 5561003, 6824907, 6847306, 5929353, 5561013, 5179799, 5061879, 5316535, 5717020, 6222496, 5561018, 6222506, 6824899, 6824888, 6824894, 5561008, 5929360, 5561004, 5929345, 6222499, 6847289, 6218740, 5929350, 6222487, 6218724, 6222486, 5929354, 5717011, 6218720, 5929358, 5717024; d) Item Number 314-02-25, UDI/DI 10885862175083, Serial Numbers: 1984594, 1984595, 1984596, 1984593, 2086796, 2147635, 2485875, 2637753, 2167696, 2147618, 2147649, 2419041, 2147644, 2142520, 3592854, 3571536, 2591549, 4555103, 4521883, 4925728, 4148695, 4607449, 5163430, 4572652, 4521882, 5543395, 4607452, 5319922, 5543410, 5543408, 5319946, 5960413, 5381658, 5960424, 4607451, 6872159, 4925733, 5319919, 5319942, 5381668, 5163412, 5960410
Exactech, Inc. is recalling Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44 due to The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Recommended Action
Per FDA guidance
Beginning 03/06/2024, Exactech issued an URGENT MEDICAL DEVICE RECALL notice and an URGENT DEAR HEALTHCARE PROFESSIONAL COMMUNICATION to its consignees via email. The recall notice explained the issue, clinical impact, and requested the following actions be taken: "" 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 customer s inventory listed Product Scope Listing. " EXTEND THE DESCRIPTION OF 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. The communication to healthcare providers referenced the FDA Safety Communication issued on 01/16/2024, explained the issue, potential health risks, and suggested patient monitoring for those with implanted affected devices for potential device wear, failure, or bone loss and should consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device. Contact your local Exactech Representative if you have any questions regarding this communication.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026