Drug recall
SeaSpine Polyaxial Head REF Number: 41-3010
FDA recall event 99221 · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Event ID | 99221 |
|---|---|
| Recall numbers | Z-2762-2026 |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Product type | Devices |
| Products | SeaSpine Polyaxial Head REF Number: 41-3010 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. |
| Initiation date | May 28, 2026 |
| Report date | Jul 29, 2026 |
| City | Carlsbad |
| State | CA |
| Country | United States |
| FEI number | 3012120772 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: