Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer — Class II medical device recall Z-0535-2026
Ongoing recall by Exactech, Inc., reported 2025-11-26. Due to products that have not completed design updates and performance testing being released/distributed. Pro
| Recall number | Z-0535-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2025-11-17 |
| Reported by FDA | 2025-11-26 |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 10885862593009 |
| Lot numbers | 410398-013 |
| Model numbers | 321-59-42 |
Product
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0535-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.