Class II — SEASPINE ORTHOPEDICS CORPORATION
| Recalling firm | SeaSpine Orthopedics Corporation |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| Product | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No |
| Quantity | 191 devices |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA. |
| Initiated | 2024-10-29 |
| Classified | 2024-12-23 |
| Recall number | Z-0752-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SEASPINE ORTHOPEDICS CORPORATION (Z-0752-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95760/
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