CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report
Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled
Seaspine Orthopedics is recalling Daytona Small Stature Ti Locking Cap, Small Stature, T25, distributed nationwide in the US. The recall was initiated on 29 Oct 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0752-2025
- FDA event ID
- 95760
- Recalling firm
- Seaspine Orthopedics, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Oct 2024
- FDA classified
- 23 Dec 2024
- Reported
- 1 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 29 Oct 2024 | Recall initiated by company | |
| 23 Dec 2024 | Classified by FDA | +55 days |
| 1 Jan 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand 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 Component: No
Where it was distributed
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Nationwide CaliforniaColoradoFloridaGeorgiaPennsylvaniaTexasVirginia
Questions about this recall
Why was it recalled?
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Which lots are affected?
Lot Code: PN 79-0001 UDI 10889981185633 Lot Numbers MM2098114B
Where was it sold?
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95760This product is part of a recall event; the main page for the event is Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled | Seaspine Orthopedics | Device Malfunction | Nationwide |
More recalls from Seaspine Orthopedics
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
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| Device | CLASS II | Reef TA Inserter recalled by Seaspine Orthopedics | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled | Seaspine Orthopedics | Device Malfunction | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
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| Device | CLASS II | Ingenia Elition S and Ingenia Elition recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |