Reported Dec 27, 2023 · Ongoing

Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, 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?

  • Exactech Optetrak Logic Knee System
  • Catalog Numbers
    • a) 02-012-47-3011
    • b) 02-012-47-5009
    • c) 02-012-47-5011
    • d) 02-012-65-3013
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct as published
1088586217435202-012-47-3011, , Serial Numbers: A676497
1088586217454302-012-47-5009, , Serial Numbers: A641353
1088586217455002-012-47-5011, , Serial Numbers: A641341
1088586261340002-012-65-3013, , Serial Numbers: A655561
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.