Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 4...
FDA Recall #Z-1407-2024 — Class II — March 6, 2024
Product Description
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
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).
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
985 units
Distribution
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
Code Information
a) Item Number 314-02-32, UDI/DI 10885862175052, Serial Numbers: 2090670, 1984370, 2086996, 2090655, 2108671, 2086997, 2086999, 2379424, 2479807, 2640374, 2142682, 2147846, 2142679, 2479798, 2090659, 2147857, 2147847, 2640379, 2090665, 2086983, 2640371, 2142675, 2147834, 2086981, 2640406, 2086998, 1984369, 2147853, 2640397, 1984379, 2628334, 2640377, 2640375, 2640384, 2752430, 3570463, 3570474, 2640372, 2142674, 1984378, 2379426, 2640380, 2640391, 2640394, 2640395, 2640403, 2640410, 2379418, 2594876, 2640385, 3616755, 3616759, 3758373, 3616754, 3570473, 2983574, 3570462, 3570461, 3570454, 1984381, 2086989, 2147814, 2086988, 2147828, 2640408, 2594877, 2958057, 3970792, 2788748, 3970793, 2752423, 3970794, 4469187, 3616757, 4587423, 2379417, 2594878, 2788750, 2752418, 3570460, 4469183, 2958061, 3570459, 4591595, 4657525, 4657526, 4807291, 4657530, 2752421, 4469189, 4209410, 3570469, 3616758, 4602056, 5349352, 4591598, 5161352, 4485953, 4141933, 4409893, 4469185, 4520246, 5540785, 5540764, 5279160, 5540774, 5540781, 5540777, 5540773, 5929633, 5929646, 4497764, 4807288, 5519031, 5161362, 5161370, 5929643, 5929635, 5929624, 4409904, 5349329, 5349336, 5349327, 6846318, 6130751, 6130754, 6130763, 6846297, 6846301, 6846314, 6823520, 4651619, 6823534, 5929622, 7008973, 7008965, 5540789, 5929640; b) Item Number 314-02-33, UDI/DI 10885862175069, Serial Numbers: 2084927, 1985029, 2084773, 2141202, 1985036, 1985027, 2084781, 2084788, 2084783, 1985020, 2084904, 2084930, 1985024, 1985031, 2084771, 2084763, 2379448, 2084766, 2084920, 2084774, 2084772, 2426118, 2084779, 2084916, 1985028, 2141200, 2084914, 2149805, 1985033, 2485893, 2084919, 2149803, 2149820, 2105746, 1985030, 1985021, 2084764, 2149823, 2149828, 2149800, 1985032, 1985026, 2105745, 2149810, 2379454, 2379466, 2426097, 2149824, 2485884, 2426446, 2084922, 2379465, 2149811, 2426423, 2426447, 2084777, 2149788, 2149809, 2426427, 2379453, 2084769, 2149832, 2426117, 2426434, 2426418, 2141204, 2426114, 2149787, 2426101, 2149831, 2084924, 2426091, 2426413, 1985023, 2426439, 2084768, 2084765, 2149801, 2485898, 2426417, 2426125, 2084931, 2426422, 2379467, 2084923, 2628343, 2426112, 2628341, 2752437, 2684242, 2684245, 2700673, 2700682, 2752438, 2684223, 2684218, 2426113, 2426105, 2426102, 2084917, 2426437, 2084770, 2084780, 2426438, 2084776, 2149816, 2149808, 2485891, 2426426, 2485890, 2485897, 2141203, 2426444, 2379451, 2485889, 2149794, 2149785, 2485894, 2084787, 2426109, 1985035, 2426428, 2149819, 2149818, 2084928, 2149815, 2426103, 2149830, 2426432, 2628344, 2628342, 2684233, 2684220, 3637081, 2752446, 2942529, 2983586, 2942544, 2752449, 2942532, 2942521, 2983591, 2684227, 2873830, 2700679, 2752442, 2942531, 2684235, 2752447, 2983590, 2752445, 2983592, 2752439, 2983598, 2684238, 3574187, 3574162, 2752431, 2752436, 2684219, 3574185, 2942536, 3574166, 3574160, 3574182, 2684217, 3574181, 2149822, 2084905, 2426120, 2149791, 2084778, 2426092, 2149817, 2426104, 2149806, 2105744, 2426424, 2426443, 2149829, 2426106, 2426441, 2141201, 2149821, 2426111, 2485882, 2426425, 2485892, 2149789, 2752440, 3925823, 2873828, 3574186, 2942542, 3637092, 2700675, 3574188, 2942545, 3896139, 2942522, 3574174, 2684229, 3812899, 2942519, 3837391, 3837393, 2942538, 3637077, 3574175, 3837384, 3574163, 2684216, 2684222, 2700672, 3837400, 3637089, 3896134, 3574173, 3637069, 3637070, 3637071, 3637072, 3637079, 3637085, 3837396, 3842912, 3842911, 2873836, 3574189, 3574170, 3574184, 3574180, 3574183, 2684239, 3637078, 2084913, 2149825, 2591552, 2426436, 2426093, 2379457, 2873825, 3574167, 4113904, 4113894, 2983595, 2684224, 3925832, 3925826, 3574171, 2700671, 3637093, 4113892, 4113901, 4551913, 4398954, 4113900, 4113890, 3842914, 3896138, 3896131, 4398959, 3842913, 3637083, 4113897, 3637067, 2873832, 3637073, 3896137, 4398961, 3637095, 2426096, 3837394, 2684228, 3925820, 3896140, 3896136, 4113881, 4398967, 4512761, 4398962, 4398963, 4113905, 4685394, 3637094, 3925825, 4113898, 3837397, 4113907, 3925833, 3574165, 4398970, 4512756, 4398955, 3925816, 4551917, 4512755, 5387840, 5519105, 5349433, 5279877, 5279797, 5387821, 4780811, 4825319, 5279863, 4113906, 3896142, 4512762, 5519103, 5387826, 4685397, 5387829, 5387824, 5875156, 5743581, 5875144, 5743582, 5875163, 5929442, 5929443, 5929449, 6129392, 6129407, 5743594, 5929452, 5875162, 6129395, 5875168, 5929468, 5929446, 4113885, 4398965, 4780809, 5349421, 4825327, 4825326, 6129402, 6129410, 5929467, 6129394, 5743593, 6389101, 5875169, 5743579, 4825318, 5349411, 5279784, 4825324, 4780817, 4825323, 5279788, 5349422, 5387822, 6389081, 6129401, 6832085, 6584616, 5743589, 6129398, 6389102, 6389096, 6584617, 6584623, 5743590, 5929445, 6129405, 5929469, 6584622, 5387837, 5279862, 5279798, 5279867, 5929459, 5743725, 6584619, 5743732, 6129409, 6389080, 6832069, 5929461, 5875157, 5929457, 5743591, 6129393, 5743592, 6832075, 5929441, 5875161, 5875146, 5929447, 6832083, 5743734, 5743585, 6832079, 6832082, 6129408, 6584631, 5743595, 6584630, 6584615; c) Item Number 314-02-34, UDI/DI 10885862175076, Serial Numbers: 1984798, 1984806, 1984812, 1984803, 2093504, 2150262, 2150261, 1984799, 1984801, 2083436, 2093481, 1984797, 1984800, 1984802, 2083426, 2083430, 2150268, 2093474, 2293111, 2293101, 2425166, 1984805, 2083450, 2083469, 2425157, 2083464, 2083432, 2093515, 2093483, 2093516, 2425180, 2150270, 2093513, 2083459, 2293104, 2150265, 2083441, 2083445, 2093505, 2093472, 2083455, 2083460, 1984809, 2482931, 2425152, 2083446, 1984810, 2093491, 2083437, 2083443, 2083440, 2293109, 2150271, 2150264, 2093497, 2093487, 2093482, 2093506, 2425162, 2425170, 2425155, 2425153, 2093521, 2093473, 2083470, 2093502, 2640438, 2093511, 2083434, 2640449, 2425169, 2425134, 2083429, 2150274, 2083427, 2293124, 2293114, 2425161, 2425138, 2093503, 2628346, 2425159, 1984808, 2482933, 2425168, 2150278, 2083442, 2093475, 2293125, 2083457, 2083471, 2640443, 2083425, 2425148, 2482937, 2482926, 2425135, 2293100, 2293105, 2482936, 2093496, 2425173, 2293106, 2150272, 2083454, 2747880, 2747861, 2425124, 2425121, 2425147, 2425128, 2425129, 2425115, 2293122, 2425127, 2083433, 2083466, 2083444, 2640427, 2640435, 2083424, 2150277, 2640426, 2093489, 2425122, 2425123, 2093514, 2425144, 2425176, 2083462, 2482927, 2482928, 2293120, 2083452, 2425154, 2293121, 2640419, 2425132, 2093476, 2093488, 2640421, 2640429, 2425126, 2640450, 2093507, 2425172, 2425185, 2640428, 2425165, 2293098, 2482929, 2640414, 3570485, 3570493, 2877202, 2877206, 2747863, 2983582, 2983584, 2747865, 3570480, 2877207, 2754566, 2747868, 3570501, 2877210, 3570487, 2877211, 3741125, 2877215, 2967532, 3570483, 3570494, 2958315, 2747869, 2754561, 2754557, 3570490, 2747872, 3570489, 2628349, 2482930, 2640447, 2425149, 2293115, 2093495, 2093484, 2083422, 2640430, 2425146, 2083439, 2093478, 2640417, 2640432, 2083456, 2640440, 1984811, 2482925, 2083458, 2293127, 2293112, 2150279, 3570484, 3826845, 3741116, 3741115, 2747871, 2958320, 2877200, 3896159, 3896169, 3795618, 3570481, 3826852, 2983581, 3685423, 2958319, 3685428, 3896166, 3570496, 2754562, 3741117, 3896151, 3685421, 3685424, 3741123, 3741124, 3795624, 3795626, 3826860, 3896163, 2747878, 2967531, 3570492, 3896177, 3685422, 2425117, 2093509, 2425137, 1984813, 2640420, 2482932, 2586933, 2640441, 2640415, 3570477, 2877198, 3826862, 3826855, 4083724, 3826854, 2754560, 2967525, 2877199, 3896165, 2747873, 4083718, 4083723, 3997148, 4083719, 3896176, 3896154, 3570482, 2640439, 2425151, 2640437, 3896153, 4470778, 4512752, 3741127, 2877212, 2958316, 2747879, 3685426, 3896178, 2877208, 4083721, 4095017, 4470772, 5076175, 5076176, 5139720, 2747874, 4470774, 4095014, 4095018, 4083717, 3896172, 3685429, 3570479, 4470779, 5168349, 5496225, 5168337, 5496219, 5168339, 5655294, 5655304, 2628347, 3795623, 3896180, 4398972, 5168338, 4765131, 5168343, 5565653, 5691680, 5655307, 5691671, 5691672, 5691660, 5967231, 5967253, 5691673, 6218710, 5655301, 5967241, 6218690, 5565656, 4095015, 5496227, 5496235, 5351507, 6389254, 6389247, 6389243, 6218704, 5565647, 5967244, 4512749, 4475619, 4790541, 4790542, 5496231, 5351518, 5280312, 4790535, 5496237, 5967230, 6218716, 5655299, 6389230, 6218706, 5691678, 5565646, 6218702, 6218713, 6623276, 6623281, 6623293, 5691666, 5691674, 5655303, 5655290, 5691663, 5691684, 5967240, 5967251, 5967229, 4475628, 5351495, 5280322, 5168340, 5351516, 5496211, 5565649, 5655302, 6218698, 5655298, 5655293, 6623289, 6905374, 6905376, 6905377, 6905380, 6905408, 5691675, 6218714, 6905412, 6905396; d) Item Number 314-02-35, UDI/DI 10885862175083, Serial Numbers: 2084874, 1985093, 1985091, 2084879, 1985097, 1985106, 1985104, 2084859, 1985102, 1985094, 2169727, 1985095, 2138724, 2138702, 2640472, 2169725, 2084895, 2084896, 2378032, 2378023, 2378019, 2169726, 2378021, 2084882, 2084857, 3571551, 2961483, 2752463, 1985096, 2640480, 2378026, 2138699, 2640495, 2378030, 2479841, 1985100, 2752457, 4523804, 4442573, 5359162, 4442577, 4442570, 5280146, 5457321, 5457335, 5957970, 5957988, 5957990, 5875196, 5875186, 5359158, 5133528, 4442575, 4466032, 5457333, 5359153, 6713270, 4523806, 5143289, 5359164, 6986597, 6986605, 6986609, 6986611, 6986614, 5511964
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated