Class II

Medical Device Recall: 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

SEASPINE ORTHOPEDICS CORPORATION · October 29, 2024

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

191 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0752-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.