CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
Truliant Knee System recalled by Exactech
Exactech is recalling Exactech 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
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
- 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
ArkansasFloridaGeorgiaIllinoisIndianaKentuckyMarylandMaineMinnesotaNew HampshireNevadaNew YorkSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Is Truliant Knee System recalled?
Yes. Exactech recalled Truliant Knee System on 21 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0585-2024.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |