SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001…

Recall date

October 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0752-2025

FDA classification

Class II

Brand / firm

SEASPINE ORTHOPEDICS CORPORATION

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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