FDA-Device2025-11-26Class IIPROCESSING DEFECT
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
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.: SC O.U.S.: N/A
Affected count
1
Manufactured in
2320 Nw 66th Ct, Gainesville, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0537-2026Want us to check the next one for you?
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