Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit… — Class II medical device recall Z-1510-2026
Ongoing recall by Exactech, Inc., reported 2026-03-18, distributed in CA, CO, FL, GA, HI, ID, IL, IN…. Impactor handle may be missing cross-pin
| Recall number | Z-1510-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2026-02-03 |
| Classified | 2026-03-09 |
| Reported by FDA | 2026-03-18 |
| Distributed | 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 |
| Countries outside the US | AE, AU, CH, DE, ES, FR, GB, IT, JP, KR, SI |
| Quantity | 596 kits |
| UPC / GTIN / UDI-DI | 10885862559166 |
| Model numbers | KIT-311X |
Product
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Reason for recall
Impactor handle may be missing cross-pin
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-1510-2026. 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.