CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report

Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled

Seaspine Orthopedics is recalling Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT, 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

Lot, batch or date codesLot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

Quantity recalled92 devices

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-0751-2025
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: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 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 California Colorado Florida Georgia Pennsylvania Texas Virginia

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 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

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 95760

Reported	Class	Recall	Company	Reason	Where
1 Jan 2025	CLASS II	Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled	Seaspine Orthopedics	Device Malfunction	Nationwide

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30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
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17 Sep 2025Device	CLASS II	Reef TA Inserter recalled by Seaspine Orthopedics	Seaspine Orthopedics	Other	Nationwide
1 Jan 2025Device	CLASS II	Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled	Seaspine Orthopedics	Device Malfunction	Nationwide

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