Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0...
FDA Recall #Z-0586-2024 — Class II — November 21, 2023
Product Description
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-024-35-2509, l) 02-024-35-2510, m) 02-024-35-2511, n) 02-024-35-2512, o) 02-024-35-3010, p) 02-024-35-3011, q) 02-024-35-3012, r) 02-024-35-3013, s) 02-024-35-3513, t) 02-024-35-3515, u) 02-024-35-4012, v) 02-024-35-4013, w) 02-024-35-4510, x) 02-024-35-4515, y) 02-024-35-5011, z) 02-024-35-5012, aa) 02-024-44-1511, bb) 02-024-44-2009, cc) 02-024-44-2011, dd) 02-024-44-2015, ee) 02-024-44-2510, ff) 02-024-44-2515, gg) 02-024-44-3009, hh) 02-024-44-3011, ii) 02-024-44-3013, jj) 02-024-44-3015, kk) 02-024-44-3509, ll) 02-024-44-4009, mm) 02-024-44-4509, nn) 02-024-44-4511, oo) 02-024-44-4512, pp) 02-024-44-4513, qq) 02-024-44-5013
Reason for Recall
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
Code Information
a) 02-023-02-0029, GTIN 10885862596376, Serial Numbers: A704613, A704614, A704618, A704633, A704634, A704649, A704651, A704632; b) 02-023-02-0032, GTIN 10885862596383, Serial Numbers: A703837, A703844, A703847, A703863, A704084, A704089, A704100, A704102, A704105, A704110, A704111, A704115, A704142, A704161, A704162, A704167, A704171, A704189, A704190, A704151, A704156, A704183; c) 02-023-02-0035, GTIN 10885862596390, Serial Numbers: A704258, A704282, A704299, A704300, A704306, A704314, A704320; d) 02-023-02-0038, GTIN 10885862596406, Serial Numbers: A704222, A704229, A704231, A704233, 704240, A704249; e) 02-024-35-1512, GTIN 10885862596741, Serial Numbers: A713224, A713230, A713233, A713234, A713237; f) 02-024-35-1515, GTIN 10885862596772, Serial Numbers: A697051; g) 02-024-35-1519, GTIN 10885862596796, Serial Numbers: A713345; h) 02-024-35-2010, GTIN 10885862596819, Serial Numbers: A701145, A701149, A701150, A701151, A701152, A701153, A701154, A701155, A701156, A701157, A701158, A701159, A701160, A701162, A701163, A701164, A701165, A701166; i) 02-024-35-2013, GTIN 10885862596840, Serial Numbers: A697420, A697421, A697423, A697424, A697425, A697427, A697428, A697430, A697431, A697434, A697435, A697437, A697438, A697439, A697440; j) 02-024-35-2015, GTIN 10885862596864, Serial Numbers: A701404, A701405, A701407, A701409, A701410, A701411, A701412, A701417, A701421, A701425, A701426, A701427, A701429, A701434; k) 02-024-35-2509, GTIN 10885862596895, Serial Numbers: A702432, A702433, A702436, A702437, A702438, A702439, A702440, A702441, A702442, A702443, A702444, A702447, A702448, A702449, A702450, A702452, A702453, A702454; l) 02-024-35-2510, GTIN 10885862596901, Serial Numbers: A713194, A713195, A713199, A713203, A713205; m) 02-024-35-2511, GTIN 10885862596918, Serial Numbers: A700853, A700855, A700857, A700859, A700863, A700865, A700866, A700869, A700873, A700874, A700876, A700877, A700880, A700882, A700883, A700887, A700891; n) 02-024-35-2512, GTIN 10885862596925, Serial Numbers: A713238, A713241, A713242, A713243, A713244, A713245, A713246, A713247, A713249, A713250, A713252, A713253, A713254, A713255, A713256, A713257, A713258, A713239; o) 02-024-35-3010, GTIN 10885862596994, Serial Numbers: A701111, A701116, A701117, A701119, A701120, A701121, A701122, A701125, A701126, A701127, A701128, A701130, A701131, A701133, A701137, A701138, A701140, A701141; p) 02-024-35-3011, GTIN 10885862597007, Serial Numbers: A707591, A707592, A707593, A707595, A707597, A707598, A707600, A707601; q) 02-024-35-3012, GTIN 10885862597014, Serial Numbers: A701456, A701458, A701459, A701460, A701463, A701464, A701465, A701466, A701467, A701468, A701469, A701470, A701471, A701472, A701473, A701474, A701476, A701478; r) 02-024-35-3013, GTIN 10885862597021, Serial Numbers: A696988; s) 02-024-35-3513, GTIN 10885862597113, Serial Numbers: A702455, A702458, A702459, A702460, A702462, A702464, A702465, A702466, A702467, A702469, A702470, A702471, A702472, A702473, A702474, A702475, A702476, A702477; t) 02-024-35-3515, GTIN 10885862597137, Serial Numbers: A707603, A707606, A707607; u) 02-024-35-4012, GTIN 10885862597199, Serial Numbers: A702364, A702365, A702366, A702369, A702370, A702371, A702372, A702373, A702375, A702376, A702377, A702378, A702379, A702380, A702381, A702382, A702384, A702385; v) 02-024-35-4013, GTIN 10885862597205, Serial Numbers: A702387, A702389, A702391, A702392, A702393, A702394, A702395, A702396, A702397, A702400, A702401, A702402, A702403, A702404, A702405, A702406, A702407, A702408; w) 02-024-35-4510, GTIN 10885862597267, Serial Numbers: A702341, A702342, A702343, A702345, A702346, A702347, A702349, A702350, A702351, A702352, A702353, A702354, A702355, A702357, A702358, A702359, A702360, A702361; x) 02-024-35-4515, GTIN 10885862597311, Serial Numbers: A707570, A707572, A707573, A707574, A707575, A707576, A707578, A707579, A707580, A707581, A707582, A707583, A707584, A707585, A707586, A707587, A707589, A707590; y) 02-024-35-5011, GTIN 10885862597366, Serial Numbers: A706709, A706710, A706711, A706712, A706714, A706715, A706716, A706717, A706719, A706720, A706721, A706722, A706723, A706724, A706726, A706727, A706729, A706730; z) 02-024-35-5012, GTIN 10885862597373, Serial Numbers: A706791, A706792, A706793, A706794, A706795, A706796, A706797, A706798, A706800, A706801, A706802, A706803, A706804, A706805, A706806, A706807, A706808, A706809; aa) 02-024-44-1511, GTIN 10885862597724, Serial Numbers: A750655, A750656, A750657, A750659, A750660, A750665, A750667, A750669; bb) 02-024-44-2009, GTIN 10885862597793, Serial Numbers: A769691, A769693, A769694, A769695, A769700, A769701, A769702, A769707; cc) 02-024-44-2011, GTIN 10885862597816, Serial Numbers: A750725, A750726, A750729, A750737, A750738, A750739, A750745, A750750; dd) 02-024-44-2015, GTIN 10885862597854, Serial Numbers: A750751, A750753, A750756, A750757, A750761, A750762, A750764, A750768; ee) 02-024-44-2510, GTIN 10885862597892, Serial Numbers: A753626, A753627, A753632, A753633, A753637, A753639, A753645, A753648; ff) 02-024-44-2515, GTIN 10885862597946, Serial Numbers: A753165, A753166, A753171, A753172, A753174, A753176, A753177, A753185; gg) 02-024-44-3009, GTIN 10885862597977, Serial Numbers: A769185, A769195, A769198, A769200, A769202, A769204, A769208, A769217; hh) 02-024-44-3011, GTIN 10885862597991, Serial Numbers: A753080, A753085, A753086, A753092, A753093, A753096, A753099, A753103; ii) 02-024-44-3013, GTIN 10885862598011, Serial Numbers: A753187, A753188, A753189, A753193, A753196, A753198, A753204, A753209; jj) 02-024-44-3015, GTIN 10885862598035, Serial Numbers: A753057, A753063, A753065, A753070, A753071, A753072, A753073, A753074; kk) 02-024-44-3509, GTIN 10885862598066, Serial Numbers: A769635, A769649, A769652, A769655, A769656, A769657, A769658, A769661; ll) 02-024-44-4009, GTIN 10885862598158, Serial Numbers: A769669, A769672, A769675, A769676, A769680, A769683, A769685, A769689; mm) 02-024-44-4509, GTIN 10885862598240, Serial Numbers: A769149, A769150, A769151, A769152, A769154, A769159, A769162, A769173; nn) 02-024-44-4511, GTIN 10885862598264, Serial Numbers: A761277, A761292, A761293, A761294, A761295, A761296, A761297, A761298; oo) 02-024-44-4512, GTIN 10885862598271, Serial Numbers: A761302, A761304, A761305, A761306, A761309, A761310, A761311, A761312; pp) 02-024-44-4513, GTIN 10885862598288, Serial Numbers: A760921, A760924, A760929, A760930, A760931, A760932, A760934, A760938; qq) 02-024-44-5013, GTIN 10885862598370, Serial Numbers: A761213, A761214, A761215, A761218, A761220, A761221, A761228, A761229
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.