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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Truliant, ActivitE

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  Class 2 Device Recall Exactech Truliant, ActivitE see related information
Date Initiated by Firm November 21, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0586-2024
Recall Event ID 93507
510(K)Number K223252  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product 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
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
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		 Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA Determined
Cause 2		 Packaging change control
Action Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Exactech, Inc
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