Device product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-32, b) 41, 44, 47, 50 head, Medium, Item Number314-06-33, c) 44, 47, 50, 53 head, Large, Item Number 314-06-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-35; Shoulder Arthroplasty
Z-1411-2024
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 94092
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 245 units
- Official record key
device-enforcement:Z-1411-2024
Official wording
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) 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
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
Derived failure modes
-
Unknown
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).