Exactech Equinoxe — Class II medical device recall Z-2562-2025
Ongoing recall by Exactech, Inc., reported 2025-09-24, distributed nationwide. Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification wi
| Recall number | Z-2562-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2025-08-15 |
| Classified | 2025-09-12 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, CO, DE, ES, FR, GB, GT, IN, IT, JP, KR, NL, SE, SI, TH, ZA |
| Quantity | 11,542 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10885862593832, 10885862593849, 10885862593917, 10885862593924 |
| Model numbers | 322-38-00, 322-38-03, 322-42-00, 322-42-03 |
Product
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)
Reason for recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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-2562-2025. 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.