Recall Z-0751-2025
Seaspine Orthopedics Corporation · initiated October 29, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Reason for recall
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA-determined 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.
Details
- Recall number
- Z-0751-2025
- Initiated
- October 29, 2024
- Posted by FDA
- December 23, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 92 devices
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
- Recalling firm
- Seaspine Orthopedics Corporation, Carlsbad, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0752-2025 Class II | Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25…Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. | 10/29/2024Open, Classified |