FDAClass IINovember 26, 2025

Brand Name: Equinoxe Ergo Product Name: Ergo Augments recall

Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description…

Why was Brand Name: Equinoxe Ergo Product Name: Ergo Augments 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001

Product
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description…
Recalling firm
Exactech, Inc.
Quantity
1
Distribution
U.S.: SC O.U.S.: N/A
Recall date
November 26, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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