The Recall Desk
HighFDA (Devices)·Z-0752-2025·Announced 2025-01-01

FDA Recalls Medical Spine Component Due to Manufacturing Defects

SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical component with a manufacturing defect that affects functionality. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been documented, per the rubric.

Plain-English summary

SEASPINE Orthopedics Corporation is recalling 191 Daytona Small Stature Ti Locking Cap 4.5mm surgical components. The devices have manufacturing defects that affect the ability for components to mate properly.

The affected locking caps (Model 79-0001, Lot MM2098114B, UDI 10889981185633) were distributed nationwide in California, Colorado, Florida, Georgia, Pennsylvania, Texas, and Virginia.

This is an FDA Class II recall. No injuries or illnesses have been reported to date.

The recalled product

Product
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
Manufacturer
SEASPINE ORTHOPEDICS CORPORATION
Category
Medical Device — Orthopedic / Surgical Component
Hazard
  • manufacturing-defect
  • component-fit-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: PN 79-0001 UDI 10889981185633 Lot Numbers MM2098114B

Distribution

Distributed nationwide across the United States.

Related recalls

Same category