CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Truliant Knee System recalled by Exactech

Exactech is recalling Truliant Knee System, distributed in 16 states. The recall was initiated on 21 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 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;

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0585-2024
FDA event ID: 93507
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2023
FDA classified: 19 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

21 Nov 2023	Recall initiated by company
19 Dec 2023	Classified by FDA	+28 days
27 Dec 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

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

Arkansas Florida Georgia Illinois Indiana Kentucky Maryland Maine Minnesota New Hampshire Nevada New York South Carolina Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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;

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 93507

This product is part of a recall event; the main page for the event is AcuMatch Hip System recalled by Exactech.

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023	CLASS II	AcuMatch Hip System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Equinoxe Shoulder System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Equinoxe Reverse Shoulder System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Optetrak Logic PS Knee System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Novation Hip System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Alteon Hip XLE Liner recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Optetrak Knee System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Truliant, Activit-E Knee Insert recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Vantage Mobile Bearing Tibial Inserts recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Optetrak Logic Knee System recalled by Exactech	Exactech	Other	16 states
27 Dec 2023	CLASS II	Vantage Ankle System recalled by Exactech	Exactech	Other	16 states

More recalls from Exactech

All 197

Reported	Class	Recall	Company	Reason	Where
18 Mar 2026Device	CLASS II	Equinoxe Core Instrument Kit recalled by Exactech	Exactech	Other	19 states
18 Mar 2026Device	CLASS II	Equinoxe Ergo Modular Impactor Handle recalled by Exactech	Exactech	Other	19 states
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Augments Pilot Tip Converter recalled by Exactech	Exactech	Device Malfunction	SC
26 Nov 2025Device	CLASS II	Equinoxe Ergo Adjustable Angle rTSA Reamer recalled by Exactech	Exactech	Device Malfunction	SC

Other Hip & Knee Implants recalls

All 3,110

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled	Howmedica Osteonics	Other	Nationwide