Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 30
Pending LLM rewrite. Source: FDA_DEVICE Z-0537-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
The recalled product
- Product
- 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
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Part Number: 301-11-11
- UDI: 10885862592934
- Lot Number: 410413-001
Distribution
Distributed in 1 state:
- SC
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