Exactech Truliant Knee System – Vacuum Bag Loss (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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;
Exactech, Inc. is recalling Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022- due to Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Recommended Action
Per FDA guidance
Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, FL, GA, IL, IN, KY, ME, MD, MN, NV, NH, NY, SC, TN, TX, VA
Page updated: Jan 10, 2026