FDA recall Z-0752-2025

SEASPINE ORTHOPEDICS CORPORATION · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-10-29
Report date
2025-01-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0752-2025