Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder...
FDA Recall #Z-1421-2024 — Class II — March 6, 2024
Product Description
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, 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
447 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) 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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated