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Recall Observatory FDA recall evidence

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

October 29, 2024

Class II

Product summary

Firm
SEASPINE ORTHOPEDICS CORPORATION
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

    reason.no_named_rule · v1.0.0

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