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
Reported: November 26, 2025 Initiated: September 5, 2025 #Z-0536-2026
Product Description
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
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 1
- Distribution
- U.S.: SC O.U.S.: N/A
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Exactech, Inc.. Units affected: 1.
Why was this product recalled? ▼
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0536-2026.
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