Device 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
Z-0751-2025
Product summary
- Event
- Event 95760
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 92 devices
- Official record key
device-enforcement:Z-0751-2025
Official wording
Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Code information: Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Distribution pattern: U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Derived failure modes
-
Unknown
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.