SeaSpine Polyaxial Head REF Number: 41-3010 — Class II medical device recall Z-2762-2026
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2026-07-29, distributed nationwide. Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
| Recall number | Z-2762-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2026-05-28 |
| Classified | 2026-07-20 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL |
| Quantity | 796 units |
| UPC / GTIN / UDI-DI | 10889981155117 |
| Lot numbers | AW199682G, AW199684G |
| Model numbers | 41-3010 |
Product
SeaSpine Polyaxial Head REF Number: 41-3010
Reason for recall
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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-2762-2026. 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.