Recall archive / FDA device enforcement
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software V... — FDA record Z-0535-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 5, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- 1
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0535-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: SC O.U.S.: N/A
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 26, 2025
- Recall initiation date
- Sep 5, 2025
- Center classification date
- Nov 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.