FDAClass IIJanuary 1, 2025

Brand Name: Daytona Small Stature Product Name: CoCr recall

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A…

Why was Brand Name: Daytona Small Stature Product Name: CoCr recalled?

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E

Product
Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A…
Recalling firm
SEASPINE ORTHOPEDICS CORPORATION
Quantity
92 devices
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Recall date
January 1, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls