Drug recall
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog…
FDA recall event 95760 · Class II · SEASPINE ORTHOPEDICS CORPORATION
Key facts
| Event ID | 95760 |
|---|---|
| Recall numbers | Z-0751-2025, Z-0752-2025 |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION |
| Product type | Devices |
| Products | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No, 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| Initiation date | Oct 29, 2024 |
| Report date | Jan 1, 2025 |
| 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: