Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 S
FDA device recall Z-0752-2025 · posted 2024-12-23 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- Action taken
- 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 Dalton.daggs@seaspine.com or Danielle Nelson-Archer at Danielle.nelson-archer@seaspine.com.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 191 devices
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
- Date initiated
- 2024-10-29
- Date posted
- 2024-12-23
- Location
- Carlsbad, CA
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