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
| # | Product as published |
|---|---|
| 1 | 02-012-35-3509 |
| 2 | 02-022-35-1509 |
| 3 | 02-022-35-1513 |
| 4 | 02-022-35-3010 |
| 5 | 02-022-35-3509 |
| 6 | 02-022-35-3510 |
| 7 | 02-022-35-3511 |
| 8 | 02-022-35-4511 |
| 9 | 02-022-44-3512 |
| 10 | 02-022-47-2509 |
| 11 | 02-022-51-4519 |
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product 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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