SEASPINE ORTHOPEDICS CORPORATION Recall 95760
Description: 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
SEASPINE ORTHOPEDICS CORPORATION Recall 95760 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0751-2025 |
| Event ID | 95760 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA. |
| Quantity | 92 devices |
| Recall Reason | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| Device Classification | 20250101 |
| Device Code Info | Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E |
| Center Classification Date | 20241223 |
| Recall Initiation Date | 20241029 |
| Recalling Firm | SEASPINE ORTHOPEDICS CORPORATION |
| Initial Notification | Letter |
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