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
Enforcement
- Recall Number
- Z-1406-2024
- Event ID
- 94092
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Exactech, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- March 6, 2024
- Classification Date
- March 29, 2024
- Address
- 2320 Nw 66th Ct, Gainesville, FL, 32653-1630, United States
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
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).
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
Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand
805 units