FDA Medical devices recall ·
Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature… recall
- Recall number
- Z-0751-2025
- Date
- (initiated October 29, 2024)
- Company / brand
- Seaspine Orthopedics Corporation
5770 Armada Dr, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 92 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 Product Description: Locking Cap Component: No
Why was it recalled?
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
States: California Colorado Florida Georgia Pennsylvania Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0751-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.