BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0751-2025 · Initiated October 29, 2024

    Recall

    Recall Number
    Z-0751-2025
    Event Number
    95760
    Firm
    SEASPINE ORTHOPEDICS CORPORATION
    FEI Number
    3012120772
    Product Code
    NKB
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 29, 2024
    Posted
    December 23, 2024
    Address
    5770 Armada Dr, Carlsbad, CA, 92008-4608

    Description

    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

    Reason

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

    Action

    Update 12/18/2024 - The firm sent an updated Customer Notification Letter on 12/12/2024 to customers that have not responded to the initial notification on 10/29/2024. On 10/29/2024, firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm has identified a nonconformance with the threads of the locking cap components that may be incongruous with optimal manufacturing specifications. The nonconformance can result in a locking cap that does not mate appropriately with the screw tulip. Customers are instructed to: -Review their inventory and return the affected part(s) using the provided label to return the inventory in their possession. Any questions contact Dalton Daggs at [email protected] or Danielle Nelson-Archer at [email protected].

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

    Quantity

    92 devices