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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93507

12 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 21, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Exactech, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

12 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 12

AcuMatch Hip System, Catalog Number 142-32-27

Z-0577-2024
Recall number
Z-0577-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

GTIN 10885862538192, Serial Numbers: A673200, A673204, A673209

Distribution pattern

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

device · product 2 of 12

Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536

Z-0578-2024
Recall number
Z-0578-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 01-030-40-0636, GTIN 10885862549655, Serial Numbers: A678476, A678485, A678486, A678495, A678508, A678516, A678819, A678820, A678822, A678826, A678827, A678832, A678845, A678847, A678855, A678859, A678863; b) 01-030-40-0640, GTIN 10885862549662, Serial Numbers: A746645, A746649; c) 01-030-42-0536, GTIN 10885862549945, Serial Numbers: A655570, A655573, A655574

Distribution pattern

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

device · product 3 of 12

Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13

Z-0579-2024
Recall number
Z-0579-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 320-36-00, GTIN 10885862086617, Serial Numbers: A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641; b) 320-36-03, GTIN 10885862086624, Serial Numbers: A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122; c) 320-36-04, GTIN 10885862086624, Serial Numbers: A685325; d) 320-36-10, GTIN 10885862086631, Serial Numbers: A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137, A695140, A695146, A695150, A695151, A695152, A695154, A695155, A695157, A695159, A695160, A695161, A695162, A695165, A695166, A695167, A695168, A716197, A716219, A716230, A716231, A716232, A716233, A716234, A716236; e) 320-36-13, GTIN 10885862086648, Serial Numbers: A696430, A696435, A696436, A696438, A696441, A696443, A696444, A696445, A696446, A696447, A696449, A696450, A696452, A696455, A696458, A696459, A696460, A696461, A696462, A696466, A696469, A696471, A696472, A696473, A696474, A696475, A696477; f) 320-38-00, GTIN 10885862086655, Serial Numbers: A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850; g) 320-38-13, GTIN 10885862086686, Serial Numbers: A679891; h) 320-40-00, GTIN 10885862535030, Serial Numbers: A641613, A641619, A641623, A641624, A641626, A641629, A641631, A641632, A688976, A688977, A688981, A688982, A688983, A688984, A688985, A688986, A688989, A688990, A688991, A688992, A688993, A688994, A688997, A688999, A689001, A689002, A689003, A689004, A689008, A689011, A689015, A689016, A689017, A689018, A689019, A689021, A689022, A689023, A689025, A715756, A715757, A715758, A715760, A715762, A715763, A715764, A715766, A715768, A715771, A715775, A750496, A750497, A750499, A750502, A750511, A750524, A750529; i) 320-40-10, GTIN 10885862535054, Serial Numbers: A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476; j) 320-42-00, GTIN 10885862086693, Serial Numbers: A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989; k) 320-42-10, GTIN 10885862086716, Serial Numbers: A685535, A685539, A685551, A685557, A685568, A685573; l) 320-42-13, GTIN 10885862086723, Serial Numbers: A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698; m) 320-46-10, GTIN 10885862086754, Serial Numbers: A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712; n) 320-46-13, GTIN 10885862086761, Serial Numbers: A662094, A685620, A685624, A685627, A773694, A773700, A773702

Distribution pattern

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

device · product 4 of 12

Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35

Z-0580-2024
Recall number
Z-0580-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 314-23-02, GTIN 10885862585288, Serial Numbers: A644041, A644042, A644043, A644044, A660121, A660122, A660124, A662676, A662681, A662684, A662685, A662688, A680284, A680285, A680288, A680289; b) 314-23-03, GTIN 10885862585295, Serial Numbers: A705013, A705015, A705017, A705019, A724643, A724644, A724645, A724649, A724650, A724653, A724654, A724655, A724660, A724662, A724664; c) 314-23-13, GTIN 10885862585318, Serial Numbers: A641342, A641343, A641348, A659643, A659645, A662713, A662714, A662715, A662716, A662717, A662718, A662722, A662728, A724502, A724505, A724509, A724512, A724519, A724520, A724521, A724522, A724529, A724531, A724535, A724542, A737352, A737356; d) 314-23-14, GTIN 10885862585325, Serial Numbers: A644055, A644056, A644057, A649227, A649231, A659611, A662730, A662731, A662732, A662733, A662734, A662736, A662737, A662743, A662744, A662745, A737404, A737408; e) 314-23-15, GTIN 10885862585332, Serial Numbers: A644011, A644012, A644013, A644015, A649151, A649157, A649158, A649160, A649161, A649162, A649164, A649165, A659613, A659614, A659615, A659616, A659617, A659620, A659622; f) 314-24-22, GTIN 10885862585349, Serial Numbers: A662708, A704921, A704924, A708554, A708559, A708560, A737109, A737114, A737115, A737117; g) 314-24-23, GTIN 10885862585356, Serial Numbers: A680327, A704932, A704936, A704939, A704941, A704943, A704945; h) 314-24-24, GTIN 10885862585363, Serial Numbers: A697922, A697923, A697928, A704996, A704997, A704998, A704999, A705000, A705001, A705002, A705003, A705004, A705005, A705007, A705009, A705011, A737098; i) 314-24-32, GTIN 10885862585387, Serial Numbers: A660114, A691515, A691522, A708328; j) 314-24-33, GTIN 10885862585394, Serial Numbers: A660130, A660135, A660137, A660139, A660140, A704661, A704662, A704665, A704667; k) 314-24-34, GTIN 10885862585400, Serial Numbers: A649166, A649168, A649169, A649170, A649175, A662702; l) 314-24-35, GTIN 10885862585417, Serial Numbers: A659658, A659663

Distribution pattern

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

device · product 5 of 12

Exactech Novation Hip System, Catalog Numbers: 134-36-45

Z-0581-2024
Recall number
Z-0581-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

GTIN 10885862024046, Serial Numbers: A763009, A763010, A763011, A763017, A763018, A763020

Distribution pattern

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

device · product 6 of 12

Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13

Z-0582-2024
Recall number
Z-0582-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 200-02-26, GTIN 10885862039576, Serial Numbers: A736412; b) 200-02-29, GTIN 10885862039583, Serial Numbers: A689481, A689501, A689515, A708024, A708032, A708035, A708038, A708050, A708077, A708082, A708092, A708100, A708111; c) 200-02-32, GTIN 10885862039590, Serial Numbers: A679528, A679530, A679539, A679547, A679550, A684414, A715781, A715800, A715804, A715824, A715828, A715924; d) 200-02-35, GTIN 10885862039606, Serial Numbers: A661377, A661380, A661381, A661391, A661395; e) 200-02-38, GTIN 10885862039613, Serial Numbers: A708298, A708300, A708301, A708304, A708316, A708320, A708324; f) 200-02-41, GTIN 10885862039620, Serial Numbers: A665568, A665569, A665575, A665578, A665581, A665582, A665584, A665585, A665586, A665588, A665592, A699428, A699429, A699433, A699437, A699444, A699449, A699450, A699455; g) 200-03-32, GTIN 10885862039651, Serial Numbers: A773440, A773441, A773470; h) 200-07-29, GTIN 10885862314277, Serial Numbers: A656015, A656020, A656022, A656026, A656030, A656031, A656032, A656033, A656035, A656038, A679488, A679495, A679498, A679508, A679516; i) 200-07-32, GTIN 10885862314284, Serial Numbers: A664708, A680022, A680031, A680034, A680039, A680041, A680044, A680049, A680071, A680072, A680073; j) 200-07-35, GTIN 10885862314291, Serial Numbers: A655621, A655637, A655640, A655641, A655656, A655657, A655659, A655667, A655676, A679417, A679418, A679421, A679453, A679462, A681114, A681132, A681135; k) 204-21-13, GTIN 10885862048165, Serial Numbers: A679949; l) 204-22-26, GTIN 10885862048288, Serial Numbers: A770137; m) 208-23-18, GTIN 10885862054289, Serial Numbers: A655685, A655691; n) 208-24-13, GTIN 10885862054340, Serial Numbers: A655589

Distribution pattern

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

device · product 7 of 12

Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

Z-0583-2024
Recall number
Z-0583-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 02-012-47-3011, GTIN 10885862174352, Serial Numbers: A676497; b) 02-012-47-5009, GTIN 10885862174543, Serial Numbers: A641353; c) 02-012-47-5011, GTIN 10885862174550, Serial Numbers: A641341; d) 02-012-65-3013, GTIN 10885862613400, Serial Numbers: A655561

Distribution pattern

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

device · product 8 of 12

Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009

Z-0584-2024
Recall number
Z-0584-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

GTIN 10885862001924, Serial Numbers: A649282, A649289

Distribution pattern

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

device · product 9 of 12

Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519

Z-0585-2024
Recall number
Z-0585-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 02-012-35-3509, GTIN 10885862304346, Serial Numbers: A730624, A730626, A730628, A730630, A730631, A730632, A730633; b) 02-022-35-1509, GTIN 10885862303974, Serial Numbers: A641578, A683756, A683757, A683758, A683759; c) 02-022-35-1513, GTIN 10885862304018, Serial Numbers: A662293; d) 02-022-35-3010, GTIN 10885862304261, Serial Numbers: A662100, A662102, A662104, A662105, A662106, A662107, A662109; e) 02-022-35-3509, GTIN 10885862304346, Serial Numbers: A652047, A652048, A652050, A652052, A652053, A652054, A730952, A730960, A730961; f) 02-022-35-3510, GTIN 10885862304353, Serial Numbers: A662121; g) 02-022-35-3511, GTIN 10885862304360, Serial Numbers: A662301, A662304, A662305; h) 02-022-35-4511, GTIN 10885862304544, Serial Numbers: A684499; i) 02-022-44-3512, GTIN 10885862305206, Serial Numbers: A641603, A641606, A641608, A641612; j) 02-022-47-2509, GTIN 10885862306326, Serial Numbers: A658478, A658486, A702263, A702265, A702267, A702268, A702269, A702271; k) 02-022-51-4519, GTIN 10885862307866, Serial Numbers: A737101, A737106, A737107;

Distribution pattern

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

device · product 10 of 12

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

Z-0586-2024
Recall number
Z-0586-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

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

device · product 11 of 12

Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

Z-0587-2024
Recall number
Z-0587-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 350-21-04, GTIN 10885862276247, Serial Numbers: A644020; b) 350-22-03, GTIN 10885862276353, Serial Numbers: A641653, A641655, A641659, A641660, A641662, A641663, A641666, A641667, A641668, A641669, A641672, A641654

Distribution pattern

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

device · product 12 of 12

Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03

Z-0588-2024
Recall number
Z-0588-2024
Initiated
November 21, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Exactech, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

a) 350-41-23, GTIN none, Serial Numbers: A658148; b) 350-42-03, GTIN none, Serial Numbers: A688867, A688880, A688864, A688868, A688870, A688872, A688873, A688876, A688879, A688881, A688882

Distribution pattern

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

Field note

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