HomeMedical Device recalls
Medium severity

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateSeptember 05, 2025
ReportedNovember 26, 2025
Recalling firmExactech, Inc.
Country / regionUnited States FL

Hazard

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

Affected products

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