Z-0751-2025Class II

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog...

Name: Z-0751-2025 Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog...
Creator: Seaspine Orthopedics Corporation
Published: 2024-10-29
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2024-10-29 / Open, Classified / root cause: manufacturing process

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of 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... on 2024-10-29. FDA classified it as Class II and gives the reason as "Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0751-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-29
Posted: 2024-12-23
Recalling firm: SeaSpine Orthopedics Corporation
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Root cause tag: manufacturing process
FDA 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 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].
Quantity in commerce: 92 devices
Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Product codes and lots: Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0751-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0751-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23
Z-0752-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-23

Product code NKB

K232566Class IINewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX SystemSeaSpine Orthopedics Corporation / cleared 2024-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)