Class II FDA device recall · Z-0586-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

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

Recall record

Recalling firm: Exactech, Inc.
Product type: Devices
Recall number: Z-0586-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Gainesville, FL
Recall initiated: 2023-11-21

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0586-2024 · Source: openFDA enforcement.