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FDAFDA · Food and drugs·Recall number Z-1412-2024

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; 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 314-13-02, UDI/DI 10885862172679, Serial Numbers: 2334190, 2334196, 2334178, 2334192, 2334193, 2330945, 2177477, 2177488, 2330864, 2330867, 2177487, 2330948, 2339049, 2452141, 2334179, 2334191, 2177486, 2334180, 2334181, 2334184, 2177485, 2330866, 2330869, 2330863, 2330949, 2330947, 2474424, 2479342, 2334204, 2330950, 2330951, 2334189, 2474441, 2474433, 2177481, 2460075, 2460078, 2177494, 2452137, 2330870, 2334185, 2452125, 2339045, 2339047, 2177484, 2334200, 2334194, 2334202, 2339052, 2177492, 2460068, 2474428, 2474435, 2474440, 2330865, 2541672, 2522113, 2452126, 2622872, 2330946, 2479332, 2479341, 2541668, 2334201, 2622842, 2479331, 2522100, 2622864, 2479325, 2479324, 2615282, 2594866, 2594857, 2334183, 2452142, 2622850, 2615269, 2452130, 2541662, 2334198, 2479346, 2594861, 2339048, 2522106, 2622824, 2622879, 2622818, 2330944, 2615262, 2479333, 2474439, 2622856, 2334182, 2460076, 2460072, 2460067, 2330943, 2460070, 2460071, 2541670, 2452132, 2177490, 2594858, 2622820, 2452138, 2334187, 2339053, 2622873, 2622838, 2622823, 2594860, 2622835, 2615271, 2522095, 2622816, 2460077, 2622826, 2622867, 2334197, 2522109, 2334177, 2622883, 2522105, 2622847, 2479347, 2634054, 2330868, 2474427, 2541663, 2452143, 2594872, 2615261, 2177495, 2622863, 2522111, 2474426, 2622854, 2622839, 2622865, 2522097, 2601953, 2334188, 2622881, 2634058, 2177483, 2634050, 2634053, 2474437, 2479343, 2622840, 2541673, 2622861, 2622855, 2615260, 2541671, 2622845, 2522112, 2339050, 2339044, 2339051, 2634052, 2479336, 2330871, 2460079, 2622817, 2541669, 2615275, 2622860, 2479319, 2615264, 2452136, 2541665, 2479329, 2622827, 2541676, 2452131, 2622834, 2474442, 2615280, 2615277, 2622880, 2479348, 2622825, 2479339, 2622836, 2479320, 2479351, 2334195, 2474423, 2474425, 2479338, 2474434, 2452139, 2594870, 2460065, 2177479, 2177482, 2479345, 2474438, 2622859, 2622837, 2622862, 2622853, 2615268, 2594859, 2622870, 2522108, 2622828, 2522101, 2522102, 2811926, 2700812, 2700821, 2811910, 2700819, 2770310, 2700813, 2770334, 2811984, 2689275, 2811929, 2770324, 2811914, 2811928, 2811978, 2770317, 2770307, 2689272, 2770316, 2770337, 2777060, 2811975, 2770336, 2689265, 2811923, 2811982, 2770303, 2700818, 2777339, 2770301, 2770330, 2777052, 2777342, 2811892, 2811901, 2777340, 2700814, 2770297, 2811919, 2777343, 2700808, 2689273, 2811995, 2811988, 2770309, 2777057, 2700809, 2811899, 2689269, 2700817, 2689270, 2811920, 2777055, 2770306, 2811904, 2811994, 2689276, 2770327, 2770314, 2777344, 2777053, 2777076, 2811970, 2689277, 2811897, 2811900, 2811891, 2811906, 2479323, 2177480, 2622858, 2334175, 2330942, 2474430, 2474429, 2622830, 2594865, 2622843, 2479326, 2622848, 2622819, 2622846, 2452144, 2615273, 2334199, 2460069, 2541664, 2622851, 2622841, 2460074, 2622884, 2634048, 2594869, 2479340, 2622878, 2479344, 2474431, 2622822, 2594863, 2615274, 2594862, 2334203, 2615278, 2594867, 2594868, 2339046, 2634049, 2479327, 2522099, 2594856, 2615266, 2479349, 2622832, 2479330, 2177493, 2615270, 2460073, 2452140, 2479350, 2479317, 2594864, 2893190, 2893189, 2893201, 2969469, 2811911, 2811903, 3556623, 2811922, 2893179, 2893210, 2770302, 2811925, 3588544, 3687003, 2770299, 2777073, 2992533, 2992522, 2992532, 2992544, 2777338, 2992519, 2893197, 3564166, 3636197, 2992503, 3564148, 3623108, 3623262, 3623260, 2914370, 3659299, 3714252, 3623250, 3714255, 2992512, 3636185, 2914401, 3556624, 2992534, 2893199, 2777059, 2770308, 2893188, 3623253, 2770298, 2914375, 2777337, 3636199, 2777068, 2992531, 3564158, 3623242, 3588542, 3636184, 3556620, 3636188, 2777058, 3636179, 3623240, 2992510, 2811979, 3564165, 2811908, 3556633, 2811989, 2992506, 3556638, 3588530, 3556621, 3636195, 3636250, 3659297, 2777062, 3623273, 3588525, 2969477, 2893192, 3636245, 3577208, 3686983, 3577214, 3556622, 2992502, 2969484, 2811976, 2811977, 2811990, 2777078, 2969479, 2770333, 2969487, 2992524, 2992527, 3623244, 3683868, 3683881, 3588539, 2893200, 2893191, 3588528, 2770305, 2893178, 2914394, 2689274, 2811913, 2
Risk classification
Class II
Area (FDA)
device
Country
United States

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