FDAFDA · Food and drugs·Recall number Z-1415-2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
Published April 10, 2024 · Recall initiated: March 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- 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
- Lot
- a) Item Number 314-13-32, UDI/DI 10885862201003, Serial Numbers: 3864654, 3864659, 4140193, 4155690, 4257179, 4250984, 4155679, 4140217, 4155678, 3864658, 4108679, 4155704, 4257186, 4257198, 3926702, 4108676, 4257194, 4108680, 3926703, 4155692, 3864663, 3864662, 3864653, 3926698, 4257174, 4108685, 4269883, 4155683, 4257173, 4108681, 4269885, 4269868, 4155685, 4155677, 4269870, 4155700, 4108682, 4108683, 4269898, 4155697, 4140198, 4257180, 4257196, 4269876, 4968395, 4684348, 4684355, 4684340, 4684354, 4808076, 4808075, 4968389, 4757115, 4684353, 4757123, 4808079, 4968386, 5067509, 4808072, 4808060, 4269872, 4257193, 3864650, 4250985, 4108678, 4108684, 4257185, 4250982, 4087951, 4269882, 4140207, 4250976, 4257187, 4269900, 3864657, 4250992, 3926700, 4269873, 4968393, 5088349, 5304460, 5304457, 4808070, 5304512, 4684342, 5304461, 5304479, 4684347, 5304478, 5519088, 5088351, 4684344, 5304475, 5519087, 4968399, 5304477, 5304485, 4684365, 4684350, 5519079, 4757113, 4757124, 5519094, 5304459, 5304487, 5519083, 4684359, 5304469, 5304486, 5563435, 5563436, 4257167, 4155705, 4140205, 4257190, 4155682, 4155715, 4250979, 4250980, 4155703, 3926701, 4269884, 4140192, 4250968, 4257175, 4155706, 4269890, 4257176, 4250983, 4155686, 4140212, 3864664, 4140200, 4269897, 4257188, 4257172, 5086602, 5304480, 4808068, 5304498, 5304470, 5304484, 5116203, 5088348, 5088350, 4808078, 4684361, 4684362, 5519093, 4684352, 5519084, 5304488, 5304465, 5519092, 4968387, 5304503, 5304500, 5304515, 4968385, 4968396, 4968388, 4757122, 5304496, 5304509, 4808067, 5304495, 5304492, 5304471, 5519082, 5304468, 5757459, 5847970, 5796866, 6064029, 5563427, 5563423, 5757446, 5796876, 5847965, 5797681, 6156648, 5847974, 6064038, 6080877, 5563439, 5847958, 5797700, 5797697, 6070767, 5847971, 5847961, 5847977, 5797680, 5757461, 4257170, 4257191, 4269877, 4155680, 4269887, 4269889, 4250971, 4257192, 4140194, 4140191, 5304456, 5304508, 5304462, 5304513, 4968400, 4684351, 5519091, 4808064, 4808077, 5067508, 5304467, 4757126, 4684360, 4684364, 5519085, 5797676, 6198971, 6064044, 6442322, 6479717, 6442332, 6442328, 6442330, 5847976, 6442312, 6330749, 6198948, 6064045, 6392153, 6064041, 5796885, 6330746, 6479710, 5847963, 6198952, 6503144, 6503126, 5797694, 6080886, 6198967, 6156633, 6330744, 6277510, 6198949, 6064043, 5797699, 6503128, 5797683, 6479704, 5797687, 6666312, 5943272, 6198947, 6064030, 6479690, 6080890, 6064034, 6277532, 6330745, 6140304, 6503125, 6064027, 5796871, 6442315, 5847981, 6080884, 5847979, 6277527, 6330748, 5797678, 5847978, 5797696, 5797682, 5304466, 4968394, 4808062, 5304514, 4757118, 5519086, 5067507, 5086601, 4968398, 5304474, 4757110, 5116206, 4684349, 5086600, 5086598, 5519090, 5116205, 5116202, 5757458, 6156654, 6821948, 6821943, 5847969, 6442316, 6821929, 5797691, 6821921, 6821925, 6821930, 5796884, 6156649, 6277526, 6330747, 6140264, 6330751, 5796875, 6070768, 6442327, 6277517, 6689573, 5796882, 5757456, 6140292, 5563426, 6330752, 6479688, 6503139, 5796867, 6479701, 6821918, 6442321, 6821932, 6140281, 6198964, 6880714, 6442313, 6140261, 5847959, 6156627, 5796881, 5797698, 6080892, 6689589, 6070769, 6064032, 6479705, 6080870, 5797679, 6277516, 6442324, 6821953, 6821912, 6689565, 5797692, 6689616, 6666322, 5797686, 6821931, 6503143, 6198960, 6156635, 6392158, 5796868, 6392149, 6821957, 6277521, 6821934, 6198953, 6140284, 6198951, 6442329, 6140273, 5563433, 6140289, 6503131, 6689625, 5796874, 6823772, 6277528, 6198961, 6080868, 5847964, 5847966, 6689623, 6080895, 6821942, 5847954, 6689584, 5797695, 6198959, 5304497, 5304473, 6880698, 6277515, 6821903, 6442331, 6140256, 6821913, 6666317, 6479715, 6666302, 6880709, 6198972, 6198954, 6080882, 6666318, 6392148, 6821945, 6277525, 5943269, 6689618, 5797677, 5796873, 6156647, 6823774, 6140287, 6140267, 6140247, 6140275, 6277520, 6140270, 6479691, 6140254, 6479695, 6140277, 6821898, 6823752, 6821909, 6880718, 6277511, 6880696, 6277507, 6156637, 6821941, 6156642, 6689567, 6070765, 6140246, 6880724, 6156628, 6
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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