[pending] Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 3
Pending LLM rewrite. Source: FDA_DEVICE Z-0536-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm 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: 321-59-46
- UDI: 10885862605535
- Lot Number: 410398-014
Distribution
Distributed in 1 state:
- SC
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