Recall archive / FDA device enforcement
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — FDA record Z-1509-2026
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 Feb 3, 2026. 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: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
- Reason
- Impactor handle may be missing cross-pin
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- 120 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1509-2026
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: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details) |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
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
- Mar 18, 2026
- Recall initiation date
- Feb 3, 2026
- Center classification date
- Mar 9, 2026
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.