Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RI

Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: a) Item Number 314-06-32, UDI/DI 10885862228345, Serial Numbers: 2665747, 2694660, 2694664, 2665744, 2618441, 2694656, 2618425, 2694647, 2811847, 3755779, 2816627, 2823580, 5654258, 5561037, 5369535, 5531306, 6251869, 5654254, 6602367, 6602371, 5654267, 6602366, 6602372, 6251862, 6602374, 6602375, 6602376, 6236784, 6236780; b) Item Number 314-06-33, UDI/DI 10885862228352, Serial Numbers: 2618447, 2618463, 2694637, 2694643, 2618457, 2694624, 2694628, 2816683, 2694627, 2694635, 2816669, 2618455, 3825300, 2823610, 2816679, 2816676, 2823603, 2694641, 2823600, 2665755, 2618460, 2618462, 3755793, 4209645, 2823598, 2694644, 2823595, 2816680, 2816667, 2694642, 2823602, 2816657, 2811751, 2823609, 2816675, 2811760, 3825299, 4209641, 2823605, 2816666, 2816670, 3825291, 2811758, 5305335, 5305330, 5551792, 3825294, 3825307, 4209638, 4209646, 5368875, 5590110, 5933303, 5933313, 5305329, 6195013, 5654283, 6195012, 5305332, 5305314, 5305322, 5551790, 5305337, 6195312, 5933316, 6195317, 6520942, 6520949, 6190106, 6190096, 6190099, 6190109, 6520940, 6520948, 6520936; c) Item Number 314-06-34, UDI/DI 10885862228369, Serial Numbers: 2618486, 2618479, 2618468, 2694559, 2694548, 2694544, 2816686, 2694555, 2618469, 2665763, 2618475, 2665760, 2665757, 2618474, 2618484, 2694553, 2816705, 2816701, 2816704, 2694551, 2694560, 2618476, 2618482, 2665764, 2816706, 2811794, 2823616, 4209654, 2816719, 3856956, 4209663, 2816692, 2811786, 4209656, 2694558, 2816709, 4209664, 2811778, 2694556, 2823620, 2816703, 2694543, 2816690, 4209666, 2823618, 4209669, 2694546, 2823626, 3856953, 2823628, 2823634, 2816712, 2811792, 2823614, 2816696, 2816687, 2811787, 4209661, 2823617, 5305873, 4811744, 4854990, 5305881, 4793714, 5305872, 5272949, 5305870, 5554843, 5554845, 3794406, 3755777, 3856954, 5305894, 5305888, 5753656, 5679293, 5579557, 5554832, 5753642, 5753638, 5369538, 5369540, 5753637, 5305883, 5305892, 5305886, 5554846, 6051510, 6718721, 6718722, 6718718, 6718723, 6718736, 6143299, 6143293, 6143295, 6051513, 5753636, 6051495, 6051583, 6051584, 6718731, 6718732, 5679292, 5753643, 5753650, 6143300, 6143307, 6718726, 6718733; d) Item Number 314-06-35, UDI/DI 10885862228376, Serial Numbers: 2618496, 2618503, 2694849, 2618502, 2618500, 2694863, 2816720, 2816749, 2694861, 2694867, 2694854, 2618489, 2694865, 2811816, 2816733, 2618492, 2823637, 2816742, 4209677, 3755785, 5730064, 3882605, 4209672, 5369463, 6372776, 6372771, 6372775, 6372770, 6372772, 6372778, 6372787