Reported Dec 27, 2023 · Ongoing

Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d)…

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

11 of 11 products

Products covered by this recall
#Product as published
102-012-35-3509
202-022-35-1509
302-022-35-1513
402-022-35-3010
502-022-35-3509
602-022-35-3510
702-022-35-3511
802-022-35-4511
902-022-44-3512
1002-022-47-2509
1102-022-51-4519
Lot codes and dates

11 of 11 products

Products covered by this recall
Model / numberProduct as published
1088586230434602-012-35-3509, , Serial Numbers: A730624, A730626, A730628, A730630, A730631, A730632, A730633
1088586230397402-022-35-1509, , Serial Numbers: A641578, A683756, A683757, A683758, A683759
1088586230401802-022-35-1513, , Serial Numbers: A662293
1088586230426102-022-35-3010, , Serial Numbers: A662100, A662102, A662104, A662105, A662106, A662107, A662109
1088586230434602-022-35-3509, , Serial Numbers: A652047, A652048, A652050, A652052, A652053, A652054, A730952, A730960, A730961
1088586230435302-022-35-3510, , Serial Numbers: A662121
1088586230436002-022-35-3511, , Serial Numbers: A662301, A662304, A662305
1088586230454402-022-35-4511, , Serial Numbers: A684499
1088586230520602-022-44-3512, , Serial Numbers: A641603, A641606, A641608, A641612
1088586230632602-022-47-2509, , Serial Numbers: A658478, A658486, A702263, A702265, A702267, A702268, A702269, A702271
1088586230786602-022-51-4519, , Serial Numbers: A737101, A737106, A737107
Amount recalled
N/A

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.