Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10,...
FDA Recall #Z-1425-2024 — Class II — March 6, 2024
Product Description
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Reason for Recall
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).
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
591 units
Distribution
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
Code Information
a) Item number 320-46-10, UDI/DI 10885862086754, Serial Numbers: 0984536, 0984533, 0984546, 1018089, 1018095, 1018091, 1018097, 1018084, 0984530, 0984547, 0984529, 0984532, 1332742, 1361390, 1545622, 1545624, 1361388, 1466508, 1466510, 1466513, 1466514, 1469127, 1466511, 1469130, 1683551, 1683520, 1683540, 1683541, 1683545, 1683548, 1683552, 1683554, 1683557, 1683515, 1332737, 1469126, 2010727, 1683514, 1683532, 1683529, 1683536, 2118729, 2118731, 2104263, 2118733, 2118732, 0984535, 1332736, 1361392, 1683527, 2010723, 1683558, 2010721, 1683523, 1683528, 2194597, 2265086, 2296247, 2296249, 2104265, 2265088, 2394874, 2394872, 2104261, 2151089, 2427260, 2427269, 2296245, 2532045, 2394871, 2296262, 2532055, 2151096, 2265081, 2532038, 2532065, 2532066, 2532061, 1466512, 1683556, 1683531, 2194603, 2427272, 2151091, 2532054, 2532053, 2532037, 2532044, 3533621, 2847727, 2847735, 1683544, 1683524, 2118730, 2104264, 2532058, 2194598, 2265090, 2532059, 2532052, 2532048, 2532035, 2532057, 2532060, 2532050, 2394868, 2847740, 2847747, 2847731, 3645487, 3905359, 3905367, 2427262, 2427264, 2532063, 2847737, 3533628, 4341764, 4341770, 3905370, 3905361, 4341771, 4426302, 4426303, 4426306, 4426308, 4426301, 3905383, 3645478, 2847744, 2847725, 3645475, 3645479, 3825547, 3825543, 4426305, 4426318, 4426313, 4341756, 4341762, 4769063, 4857596, 4719181, 4805400, 5076014, 5013622, 5013621, 4805392, 4719182, 4857595, 4944150, 4944152, 4857603, 4805402, 5076021, 5013616, 5013637, 4944148, 3533623, 2847746, 4341760, 3825534, 3905360, 4341758, 3905374, 3905373, 4769064, 4944159, 4803379, 4805406, 5013632, 5044684, 5013615, 5013635, 4944154, 4805401, 4857600, 4769070, 5165732, 5165740, 5165745, 5044679, 3825535, 3905377, 3825538, 3825551, 4805382, 5044682, 5013626, 5165747, 5076023, 4944168, 4805379, 4805381, 4805384, 5165757, 5867596, 6271755, 6271759, 5867598, 5867608, 4426309, 4805385, 4944149, 5165756, 5013628, 5165752, 4944161, 5013617, 6347991, 5867602, 6271743, 6271750, 6271742, 6347969, 6594357, 4944163, 5013620, 4857593, 4769073, 5076013, 4857604, 4857606, 4756178, 4719185, 6271751, 6271744, 6271762, 6271746, 6594355, 5013633, 5044690, 6347990, 5867583, 5867590, 6347997, 5867593, 6347968, 6271763, 6594360, 6347988, 5867601, 5867594, 6347970, 6594353, 6594359, 6594345, 6271760, 6594343; b) Item Number 320-46-13, UDI/DI 10885862086761, Serial Numbers: 0983443, 0983412, 0983426, 0983423, 0983430, 1069733, 1069752, 1069781, 1069734, 0983434, 0983417, 1069736, 1069735, 0983425, 0983442, 0983427, 1069757, 0983414, 0983419, 0983435, 1069761, 1069773, 1069738, 1069740, 1069747, 1490759, 1490757, 1490762, 1490753, 1546325, 1069770, 1069767, 1490755, 1546322, 1546323, 1546326, 1802197, 1686810, 1802204, 1802901, 1686806, 1686816, 1686821, 1802200, 1802902, 1802904, 1802198, 1686811, 1802196, 1069776, 1069765, 0983436, 1069777, 1490758, 1990103, 1917844, 2027971, 1939803, 1802201, 2027968, 2027972, 2108016, 2108017, 2108013, 1990105, 1686805, 1939802, 2229147, 2132339, 2296907, 2296898, 2296901, 2296911, 2131629, 2229137, 2296897, 2392588, 2392596, 2392600, 2418293, 1546324, 2296905, 2229143, 2131627, 2513181, 2392587, 2418290, 2513173, 2296904, 2296899, 2296888, 2392593, 2392605, 2505459, 2392594, 1802205, 1686812, 1686824, 2505455, 2296908, 2296915, 2296891, 2173989, 2513193, 2418281, 2513179, 2392598, 2513188, 2513183, 2252628, 2513195, 2229150, 2513176, 2834933, 2834945, 2834957, 2834946, 2834947, 1990104, 1939806, 1990101, 2229141, 2513175, 2296889, 2132336, 2513185, 2513186, 2505457, 2296919, 2418278, 2173987, 2418292, 2296900, 2513184, 2131626, 2513190, 2988513, 2988494, 2988514, 2988509, 2795053, 2795052, 2795051, 2795054, 2988503, 2988518, 3901534, 3901529, 3901531, 4115341, 3901523, 2418286, 2392599, 2296892, 2418285, 2513177, 2513172, 2513191, 2132334, 2834934, 2988507, 2834953, 2834939, 2795050, 3901513, 3901528, 3886029, 4115340, 4309970, 4387134, 4127396, 4127400, 4309979, 3901521, 2988521, 2988510, 3901512, 4387118, 4309977, 4127406, 4387116, 4127402, 3901519, 4309976, 4703255, 4963999, 4827125, 4788000, 4827130, 4827145, 4977223, 5027773, 4902312, 5074892, 4902309, 4703261, 4703258, 4703253, 5017482, 4902313, 4827135, 4902311, 4827131, 4827142, 2988497, 2988515, 4309969, 4387131, 4127404, 4309981, 3901530, 4387122, 4127398, 4827120, 4846562, 5017483, 4801490, 4703262, 4827144, 4788001, 5049876, 4977228, 5150219, 4975984, 5027775, 5062075, 4788003, 5207482, 4769028, 4780644, 4691479, 4703266, 5150207, 5150210, 5207471, 4703248, 2988519, 3901520, 3901525, 4115338, 3886033, 4387113, 4387114, 3886028, 4309974, 3901526, 4780641, 5150211, 5017481, 4801495, 4703264, 5074890, 5207476, 5207478, 5207472, 5207480, 4827132, 4691475, 6164395, 5874286, 5874267, 5874265, 6164414, 5874264, 4309968, 4127417, 4127403, 5017485, 5150201, 5062077, 5062083, 4964000, 5027774, 4975985, 4827133, 5874273, 5874260, 6164394, 5874280, 5874281, 5874287, 6164421, 5874270, 5874283, 5874262, 6709483, 4387130, 4309966, 5049878, 5150217, 4827146, 4902315, 4703269, 4703260, 5074891, 5150209, 4780643, 6164401, 5874284, 5874277, 6164405, 6356447, 6164409, 6709485, 6593476, 6593475, 6709475, 6593467, 6709500, 5150220, 5074889, 4975981, 4977225, 6164397, 6356450, 6164399, 6593480, 6593491, 6593486, 6593459, 6709465, 6709481, 6593471, 6709472, 6709484, 6356435, 6164422, 5874274, 6164410, 6356437, 6356434, 6164408, 6593478, 6709493, 6593474, 6593485, 6593473, 6709489, 6593457, 6709468, 6709491, 6164412
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated