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Exactech, Inc. Recall 94092

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

Exactech, Inc. Recall 94092 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1421-2024
Event ID94092
Event DescriptionExactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Product TypeDevices
DistributionNationwide 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
Quantity447 units
Recall ReasonThe 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).
Device Classification20240410
Device Code Infoa) 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;
Center Classification Date20240329
Recall Initiation Date20240306
Recalling FirmExactech, Inc.
Initial Notification Letter
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