Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Ve
Summary
The FDA issued a Class II for Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Mode by Exactech, Inc.. Reason: Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and per.
Details
Source
Device Recall
External ID
Z-0537-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
Quantity Affected: 1
Reason for Recall
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Distribution
U.S.: SC O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-05
Company
Gainesville, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Exactech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exactech, Inc. have FDA actions?
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0537-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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