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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 191
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
Part of a larger recall action
This product is one of 2 recalled by SEASPINE ORTHOPEDICS CORPORATION under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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