PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 1, 2025 Initiated: October 29, 2024 #Z-0751-2025

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.

Details

Units Affected
92 devices
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 92 devices.
Why was this product recalled?
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0751-2025.