Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT M...

FDA Device Recall #Z-0751-2025 — Class II — October 29, 2024

Recall Summary

Recall Number Z-0751-2025
Classification Class II — Moderate risk
Date Initiated October 29, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SEASPINE ORTHOPEDICS CORPORATION
Location Carlsbad, CA
Product Type Devices
Quantity 92 devices

Product 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

Reason for Recall

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Distribution Pattern

U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

Lot / Code Information

Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

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Z-2554-2025 Class II Reef TA Inserter, Part Number: TA2-001003, part... Aug 6, 2025
Z-0752-2025 Class II Brand Name: Daytona Small Stature Product Name... Oct 29, 2024
Z-2357-2024 Class II Brand Name: Meridian Angled Awl Fixed Product ... Jun 4, 2024
Z-2235-2024 Class II Brand Name: Fathom Pedicle-Based Retractor Pro... May 17, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.