FDA-Device2025-01-01Class II

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
Hazard

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

Sold states
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Affected count
92 devices
Manufactured in
5770 Armada Dr, Carlsbad, CA, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0751-2025

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