Exactech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1417-2024)

Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

Class II

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 320-36-10, UDI/DI 10885862086631, Serial Numbers: 2608259, 2878175, 3759662, 3759663, 3810144, 3810149, 3786337, 3872525, 3872529, 3872524, 3872528, 3872526, 3872520, 3872535, 3872523, 3872539, 3872521, 3872534, 3872533, 3872537, 3872522, 2608258, 3872538, 3872536, 4124979, 4124982, 4124983, 4124978, 4291229, 4291226, 2878177, 4291213, 4124977, 4291230, 5027717, 3786334, 3872527, 4888837, 4888833, 5027713, 4988489, 4988487, 5027718, 4888828, 5165724, 5165727, 5165729, 4291218, 4291227, 3872531, 4291221, 4291228, 4291234, 4291225, 4291220, 5027706, 5027712, 5165730, 4696503, 4794697, 4696499, 4794698, 5165725, 4794699, 5869637, 5874634, 5869433, 5874635, 5869631, 5874638, 5869472, 5874626, 5909270, 5869429, 5869638, 5869450, 6167632, 5909268, 5869418, 5869422, 5909261, 5909266, 4291209, 4291231, 4794696, 5165722, 4988486, 4888836, 5869629, 6105291, 5869630, 6167625, 6023991, 6167650, 5869439, 6167646, 6522758, 6167637, 6190136, 6105269, 5869425, 6105281, 6064916, 6049281, 6167628, 6167644, 6190164, 6411847, 6190200, 6190139, 6049285, 6064914, 6008302, 5869475, 6044055, 6064921, 6064918, 6190229, 6167627, 6167652, 6190176, 6044060, 6190216, 5909259, 6105292, 6190171, 6522745, 5874639, 6553343, 6553295, 6593394, 6418061, 4988494, 4988493, 5869463, 6522759, 6008270, 6008278, 6522764, 6167648, 6167653, 6167630, 6044056, 5869443, 6008301, 6190135, 6008265, 6064908, 6008276, 5869437, 6483972, 6522742, 6167643, 6167611, 6008287, 6522768, 6023885, 6483986, 6008291, 6411835, 5869420, 5869459, 5869444, 6483966, 6190166, 6023973, 6167642, 6008283, 6190219, 6522770, 6105276, 5869438, 5869417, 6522731, 6190224, 6522761, 6023984, 6105289, 6190168, 5909267, 6008258, 6190198, 6190162, 6484020, 6394867, 6394854, 6167615, 6522744, 6064928, 6008290, 6190163, 6522779, 6167655, 6522736, 6008300, 6008256, 6023894, 6190126, 6049286, 6105267, 6044053, 6064915, 6064905, 6483973, 6105294, 6008284, 6522771, 5869435, 6008310, 5874636, 5874617, 6167612, 6418069, 6553339, 6418077, 6418072, 6713228, 6553334, 6418059, 6593370, 6553333, 6567052, 6713255, 6553293, 6593369, 6713249, 6713194, 6713221, 6593399, 5165721, 4988492, 5027709, 4988488, 6411842, 6190175, 6023902, 6483950, 6167620, 5869428, 6483951, 6483984, 6484005, 6044057, 6008296, 6411833, 6049283, 6167657, 6483976, 6190145, 6064912, 5869454, 6105266, 5874610, 6105280, 6483959, 6483991, 5869453, 6023981, 6484006, 6105295, 6483982, 6394881, 5869639, 6023890, 6394883, 5874615, 6044063, 6167641, 5869452, 6023982, 6023889, 6044064, 6483971, 6411843, 6008308, 6008279, 6167619, 6484007, 6394869, 6190227, 6190124, 6411846, 6064923, 6483983, 6008257, 5909260, 5909274, 6008269, 6023887, 6105265, 6190230, 6008294, 6190209, 6064920, 6064906, 6023972, 6105287, 6167636, 6008299, 6008251, 6522777, 6008262, 6167618, 6190161, 6023983, 6064910, 6023886, 6049288, 6394878, 6190148, 6190228, 6418064, 6713252, 6713211, 6713251, 6713239, 6713207, 6593443, 6418066, 6553342, 6713209, 6418060, 6553321, 6713210, 6713219, 6713232, 6593430, 6593368, 6593393, 6593415, 6553288, 6593387, 6593450, 6593439, 6418056, 6553344, 6567042, 6567053, 6553311, 6713227, 6713222, 6593423, 6713248, 6713244, 6567027, 6593410, 6593385, 6167614, 6023988, 6411841, 6394874, 5874618, 5869462, 6105282, 6190137, 6484000, 6483981, 6190220, 6394876, 6008280, 6483953, 6522739, 5869440, 6190150, 6008263, 6008254, 6023893, 6008289, 5869446, 6190199, 6484010, 6190214, 6044062, 6064929, 6484016, 6483980, 6105286, 6190206, 6190218, 6190194, 5869632, 6008306, 6008309, 5869423, 6484009, 6023979, 6411837, 6190128, 6167645, 6522737, 6394865, 6008271, 6008307, 6484017, 6049287, 6190179, 5869432, 6190207, 6190191, 6190195, 6008268, 5909258, 6049282, 6522773, 6484015, 6190203, 6522786, 6483998, 5909277, 6713203, 6418067, 6567060, 6567044, 6553318, 6567037, 6713193, 6593447, 6553325, 6593432, 6593438, 6593383, 6593377, 6713218, 6553303, 6593431, 6593451, 6418071, 6713215, 6713235, 6567047, 6713229, 6553291, 6593375, 6713240, 6418076, 6064932, 6190133, 6044046, 6064919, 6713234; b) Item Number 320-36-13, UDI/DI 10885862086648, Serial Numbers: 1954420, 2256738, 3758542, 3758543, 3800198, 3800191, 3800197, 3800200, 3800207, 3800203, 4018906, 2668553, 3758540, 3758541, 4113875, 4113876, 4425495, 4425498, 4078885, 2668555, 4679675, 4806827, 5035254, 5062750, 4113874, 4425500, 4113873, 4968116, 4679689, 5062753, 5062744, 4806821, 4679673, 5223272, 5223271, 4968117, 5062749, 5223259, 4806818, 5062745, 4806826, 5062747, 5223260, 5223277, 4679677, 4679681, 3800190, 3800202, 4806819, 5223263, 5223273, 4968121, 5062752, 4679674, 4968118, 5223261, 5223257, 5910702, 6168427, 5937181, 5910526, 5910715, 5937185, 5937159, 6007601, 5869649, 5869650, 5910710, 5910716, 4888945, 4673785, 5223255, 5223269, 5223268, 5223267, 4679685, 5910699, 6044092, 6044086, 6484059, 6168462, 6168458, 6542083, 6169849, 6007574, 5910527, 6062073, 6007609, 6168457, 6023085, 5910529, 6484067, 6007605, 6023087, 6022405, 5910705, 6189457, 6189453, 6502660, 6189442, 6542098, 6007597, 6189439, 6484068, 6007584, 6007573, 6189412, 5910720, 6189461, 6007589, 5937179, 6023099, 6484080, 6062089, 6189465, 5869645, 6168452, 6170395, 6007577, 6007621, 6189429, 5910724, 6542101, 6502664, 6170383, 6170385, 6170403, 6170407, 6170408, 5910515, 6007588, 6553391, 6460537, 4425497, 5035248, 5035251, 4679682, 5035257, 6170390, 6007596, 6484052, 6044082, 6023083, 6189416, 6538322, 6484066, 5910524, 6044081, 6189432, 6007626, 6170421, 6484106, 6484109, 6502654, 6022397, 6170417, 6023088, 6538344, 6170386, 6022381, 6484112, 6484079, 6007599, 6168453, 6007619, 6170392, 6007627, 6044080, 6007578, 6538334, 5910514, 6538323, 6044066, 6502666, 6484120, 6220198, 6168441, 6168443, 5910531, 6189408, 5937164, 5910718, 6484100, 6168419, 6502657, 6023097, 6007616, 6168430, 6044068, 6170409, 6168420, 6484108, 6170398, 6484121, 6484087, 6542108, 6169857, 6553352, 6553378, 6554480, 6460534, 6553359, 6554518, 6554520, 6553392, 6553348, 6553345, 6553372, 6460546, 6554509, 6460552, 6554516, 6554523, 6554496, 5035249, 5062742, 5223258, 6189420, 6220183, 5910697, 6170387, 6007598, 5910709, 6542111, 6189426, 6007586, 6538347, 6168450, 6502646, 6044089, 6007590, 6484117, 6169851, 6022398, 6062079, 6220199, 6044078, 6189419, 6538330, 6168423, 6484064, 6168436, 6169847, 6502663, 6538332, 6484089, 6022378, 5937176, 6220190, 6189407, 6170425, 6189404, 6007587, 6170401, 6220195, 6007572, 5910530, 5910723, 5910519, 6542087, 6169860, 6169859, 6044077, 6538337, 6189451, 6542110, 6044091, 6022389, 6484091, 6542088, 6484050, 6484101, 5910711, 6484086, 6022388, 6022394, 6502659, 6189418, 6062085, 6007610, 6502649, 6484072, 6593340, 6593318, 6553350, 6554466, 6593360, 6593343, 6554473, 6554494, 6553374, 6553375, 6554505, 6553390, 6554476, 6554512, 6553371, 6553368, 6460536, 6553369, 6553373, 6554528, 6593365, 5910695, 6168461, 6484119, 6220184, 6220186, 5937178, 6168456, 6007617, 6484076, 6538351, 6170412, 6220182, 6169867, 6189459, 5910701, 6007603, 6484102, 6502655, 5869647, 6168445, 6538340, 6044085, 6007592, 6484122, 6170405, 6170384, 6168446, 6189403, 6189444, 6170394, 6062088, 6170389, 5910534, 5937172, 6007629, 6542097, 6170397, 6189425, 6542086, 6542099, 6044067, 6007634, 5910520, 5910538, 5937189, 6170391, 6189421, 6189435, 6007614, 5910700, 6484118, 6220177, 5910521, 6538335, 6538350, 6022396, 6189414, 6554515, 6593341, 6553363, 6593339, 6554525, 6554467, 6554501, 6593336, 6612243, 6460563, 6554502, 6553347, 6553358, 6711775, 6593363, 6460549, 6593332, 6460551, 6593351, 6711782, 6554526, 6044072, 6170410, 6022399, 6542093, 6542107

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

Voluntary: Firm initiated