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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Daytona Small Stature Locking Caps Recalled for Manufacturing Defects

Agency Publication Date: December 23, 2024
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Summary

SeaSpine Orthopedics Corporation has recalled 283 Daytona Small Stature Locking Caps, including cobalt chrome and titanium models. These surgical components were found to have manufacturing defects that prevent the parts from fitting together correctly during assembly. This recall affects specific units distributed to hospitals and surgical centers in several states, though no injuries have been reported.

Risk

If the locking caps do not fit properly during a spinal procedure, it could cause surgical delays while staff locate a replacement or result in the device failing to secure correctly. While no injuries are reported, a defect in the locking mechanism poses a risk to the integrity of the surgical implant.

What You Should Do

  1. This recall affects Daytona Small Stature Locking Caps, specifically the titanium model (catalog 79-0001) and the cobalt chrome model (catalog 79-0002).
  2. Check your surgical inventory for cobalt chrome caps with lot numbers MM1002742E or MM1003065E, or titanium caps with lot number MM2098114B.
  3. Stop using the recalled device. Contact SeaSpine Orthopedics Corporation or your distributor immediately to arrange for the return, replacement, or correction of the affected units.
  4. Call the FDA at 1-888-463-6332 if you have additional questions or need to report a problem with the device.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: CoCr LockingCap 4.5mm, Small Stature, T25, BTby Daytona Small Stature
Variants: Cobalt Chrome (CoCr)
Model / REF:
79-0002
Lot Numbers:
MM1002742E
MM1003065E
UDI:
10889981185640

Recall #: Z-0751-2025; Quantity: 92 devices

Product: Ti Locking Cap 4.5mm, Small Stature, T25by Daytona Small Stature
Variants: Titanium (Ti)
Model / REF:
79-0001
Lot Numbers:
MM2098114B
UDI:
10889981185633

Recall #: Z-0752-2025; Quantity: 191 devices

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95760
Status: Active
Manufacturer: SEASPINE ORTHOPEDICS CORPORATION
Sold By: Hospitals; Surgical centers
Manufactured In: United States
Units Affected: 2 products (92 devices; 191 devices)
Distributed To: California, Colorado, Florida, Georgia, Pennsylvania, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.