Exactech, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1421-2024)

Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, 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) 320-40-10, UDI/DI 10885862535054, Serial Numbers: 5937242, 5910691, 5937233, 5936848, 6062040, 5936849, 6197662, 6197672, 6197682, 6197680, 6197683, 6197674, 6413423, 6062107, 6200990, 6046848, 6197006, 6062047, 5910110, 6413379, 6198008, 6197004, 5936902, 6484655, 5937219, 6197676, 5936834, 6533569, 6197660, 5936882, 6533590, 5910120, 6046849, 6046836, 6062039, 6046843, 6046847, 6413376, 6533602, 6533603, 6533605, 6533593, 6533595, 6533596, 6197026, 6484652, 6484654, 6484665, 6484672, 6198014, 6646211, 5910690, 5936906, 6198016, 6046852, 5937248, 5937208, 6533421, 5936873, 6533292, 6200998, 5936825, 6200968, 6533303, 5910109, 6197681, 5937249, 5937216, 6413403, 6198001, 6197003, 6533302, 6200966, 5937235, 6062099, 6062068, 6197025, 6062095, 6646201, 6673947, 6413375, 6062034, 5937245, 6198002, 6062042, 6413412, 5936866, 6062096, 5910123, 6062051, 6062036, 5936910, 6200985, 5936878, 6200982, 6533422, 6413386, 6197667, 5936869, 6197005, 6200976, 6413408, 6197663, 5937234, 6200973, 6062069, 5937236, 6533279, 5937241, 6533424, 6046833, 6062046, 6197008, 6533579, 6533577, 6046839, 5937240, 5936890, 5937192, 5936831, 6197995, 5910112, 6198009, 6062065, 6533448, 5936846, 5936821, 6413421, 5936850, 6062033, 5910116, 6533429, 6413406, 6533571, 6561069, 6561068, 6673953, 6673959, 6733646, 6673963, 6413380, 6197669, 6413420, 6413405, 6201008, 6197664, 5910108, 6533581, 5937244, 6533270, 5936897, 6062097, 6062037, 5936857, 6413388, 6413385, 6197679, 5910694, 6533280, 6533288, 6046845, 6062100, 6484658, 5936868, 6062070, 6200972, 6198015, 6197996, 6533283, 6197677, 5910127, 5936908, 6484674, 5937238, 6413424, 6200995, 6533295, 6046841, 5936898, 5910124, 6200992, 6046826, 6533442, 6046854, 6533438, 6197666, 6646235, 6646214, 6561058, 6646233, 6750051, 6673951, 6788613, 6733650, 6646202, 6561057, 6750057, 6561063, 6788604, 6750060, 6533567, 6198004, 5937215, 5937230, 6046829, 6533601, 6936457, 6936444, 6733638, 6673957, 6936431; b) 320-40-13, UDI/DI 10885862535061, Serial Numbers: 5958375, 6167598, 5958397, 5958376, 5958019, 6040054, 5869660, 6007206, 5958036, 6007204, 6040038, 6040041, 6252797, 6252808, 6008371, 6053048, 6040057, 6052792, 6007215, 6007265, 6484864, 6259930, 6008365, 6167606, 5958395, 6008354, 5958023, 6053042, 6007213, 5958035, 6259914, 6046949, 6046945, 6170267, 6252800, 6046941, 6259924, 6533939, 6533942, 6484863, 6484867, 6484874, 6484895, 6533945, 6533946, 6575118, 6575140, 6575136, 6575153, 6575167, 6008367, 6252804, 6528111, 6046567, 6528096, 6007243, 5958043, 6007262, 5958377, 6528124, 6008360, 6046948, 6046950, 6484881, 6484904, 5958044, 6046588, 5958037, 6052784, 6170272, 6398022, 6170269, 6046578, 6401912, 6052797, 6170278, 6007259, 6528106, 5958039, 6007210, 6040036, 6052798, 5869659, 5958028, 6008357, 6040056, 6052789, 6575120, 6575105, 6575117, 6730581, 6575113, 6007250, 6008363, 6528085, 6259916, 6007198, 6167591, 6484869, 6528092, 5958384, 6170277, 6052794, 6528078, 6528100, 6053063, 6528094, 6484873, 6007193, 6398012, 6170260, 6007255, 6170271, 6252812, 6398020, 6401906, 6053046, 6046929, 6167587, 6170258, 6053047, 6040037, 6046933, 6397999, 6484896, 6007214, 6046574, 6053049, 6008364, 6528064, 5958022, 6528081, 6046585, 6401905, 6007194, 6252801, 6730584, 6575162, 6575164, 6646308, 6575103, 6730086, 6730056, 6730572, 6575111, 6730063, 6730586, 6575144, 6575130, 6575142, 6730571, 6575148, 6730602, 6575150, 6575165, 6575110, 6575116, 6730084, 6398000, 6053052, 6053055, 6046583, 6401913, 6252794, 6167589, 6484880, 6167596, 5958380, 6484876, 5958367, 6401908, 5958042, 5958393, 6484898, 6040031, 6533940, 6167604, 6052804, 6398001, 6259909, 6401889, 6528120, 6040051, 6040034, 6007209, 6401898, 6046938, 6046940, 6046925, 6167595, 6008366, 6528093, 5869658, 6528099, 5869662, 5958387, 5958391, 6398015, 6007202, 6484893, 6259912, 6046582, 6167593, 6007241, 6046570, 6167603, 6167607, 6484909, 6167609, 6046572, 6259934, 6252802, 6575138, 6646316, 6575151, 6575173, 6575159, 6730579, 6730059, 6575107, 6575169, 6575170, 6730089, 6575109, 6730566, 6646303, 6730567, 6730078, 6397993, 6046936, 6528075, 6040028, 6167600, 6528073, 6401887, 6730599;

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