Reported Nov 26, 2025 · Ongoing
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software…
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?
- Brand NameEquinoxe
- Ergo Product NameErgo Augments Pilot
- Tip Converter Model/Catalog Number301-11-11
- Software VersionN/A
- Product DescriptionPilot
- Tip Converter Piece ComponentNot a component
- Lot codes and dates
- Lot CodePart
- Number301-11-11
- UDI10885862592934
- Lot Number410413-001
- Amount recalled
- 1
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
This product could cause temporary or reversible health problems — stop using it.
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