Reported Jan 1, 2025 · Ongoing
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001…
Seaspine Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEASPINE ORTHOPEDICS CORPORATION · 5770 Armada Dr · Carlsbad, CA · 92008-4608
Is this the product you have?
- Brand NameDaytona
- Small Stature Product NameTi Locking Cap 4.5mm, Small Stature
- T25 Model/Catalog Number79-0001
- Software VersionN/A
- Product DescriptionLocking
- Cap ComponentNo
- Lot codes and dates
- Lot CodePN 79-0001 UDI 10889981185633 Lot Numbers MM2098114B
- Amount recalled
- 191 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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