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
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | September 05, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | Exactech, Inc. |
| Country / region | United States FL |
Hazard
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Affected products
- Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA R
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