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Recall Observatory FDA recall evidence

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

March 06, 2024

Class II

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

    reason.no_named_rule · v1.0.0

    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).