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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

FDA Recall Z-0751-2025 · Posted 2024-12-23

Recalling FirmSEASPINE ORTHOPEDICS CORPORATION
Recall StatusOpen, Classified
Product CodeNKB
Date Initiated2024-10-29
Product Quantity92 devices

Reason for Recall

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

Firm 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].

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX SystemSeaSpine Orthopedics Corporation · 2024-04-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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