Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79
Summary
The FDA issued a Class II for Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small St by SEASPINE ORTHOPEDICS CORPORATION. Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate..
Details
Source
Device Recall
External ID
Z-0751-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Quantity Affected: 92 devices
Reason for Recall
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-29
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEASPINE ORTHOPEDICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEASPINE ORTHOPEDICS CORPORATION have FDA actions?
SEASPINE ORTHOPEDICS CORPORATION has 30 FDA actions in our database, including 9 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0751-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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