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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Exactech, Inc.
Reason for Recall:
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1406-2024

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