Z-0751-2025 Class II Ongoing

Recalled by SEASPINE ORTHOPEDICS CORPORATION — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
January 1, 2025
Initiation Date
October 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92 devices

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.

Distribution Pattern

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

Code Information

Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E