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
- Company
- Seaspine Orthopedics Corporation
- Recall Initiated
- October 29, 2024
- Posted
- December 23, 2024
- Recall Number
- Z-0752-2025
- Quantity
- 191 devices
- Firm Location
- Carlsbad, CA
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.
Lot / Code Info
Lot Code: PN 79-0001 UDI 10889981185633 Lot Numbers MM2098114B
Root Cause
Nonconforming Material/Component
Action Taken
Update 12/18/2024 - The firm sent an updated Customer Notification Letter on 12/12/2024 to customers that have not responded to the initial notification on 10/29/2024. On 10/29/2024, firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm has identified a nonconformance with the threads of the locking cap components that may be incongruous with optimal manufacturing specifications. The nonconformance can result in a locking cap that does not mate appropriately with the screw tulip. Customers are instructed to: -Review their inventory and return the affected part(s) using the provided label to return the inventory in their possession. Any questions contact Dalton Daggs at Dalton.daggs@seaspine.com or Danielle Nelson-Archer at Danielle.nelson-archer@seaspine.com.