SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-0751-2025
• FDA 510(k) clearance · K232566The device's official FDA premarket clearance record
• FDA device classification · NKBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3070The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SEASPINE ORTHOPEDICS CORPORATIONSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.