Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty

Reason: 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).

Code information: 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;

Distribution pattern: 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