Recall Z-0751-2025 ยท NKB Thoracolumbosacral Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION
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
| Date | Dec 23, 2024 (initiated Oct 29, 2024) |
| Status | Open, Classified |
| Reason | Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. |
| Root cause | Nonconforming Material/Component |
| Action | 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 affec |
| Quantity | 92 devices |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner SeaSpine Orthopedics Corporation, Apr 19, 2024 |