Daytona Small Stature recallZ-0751-2025 · Seaspine Orthopedics Corporation · initiated Oct 29, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seaspine Orthopedics Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] or Danielle Nelson-Archer at [email protected].
Recall details
- Recall number
- Z-0751-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 29, 2024
- Posted by the FDA
- Dec 23, 2024
- Recalling firm
- Seaspine Orthopedics Corporation
- Quantity
- 92 devices
- Product code
- NKB
- FDA submissions
- K232566
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
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
Code information (models, lots, serial numbers)
Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Daytona® Small Stature 79-0002Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall13 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95760).
- Z-0752-2025 · Open, ClassifiedBrand 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 Compon…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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