Class II Recall

Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-003

Summary

The FDA issued a Class II for Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, by Exactech, Inc.. Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag..

Details

Source

Device Recall

External ID

Z-0586-2024

Action Date

2023-12-27

Status

Ongoing

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

Lot/Code Info: 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

Quantity Affected: N/A

Reason for Recall

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-21

Company

Exactech, Inc.

Gainesville, FL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exactech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Exactech, Inc. have FDA actions?

Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0586-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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