Recall Z-0752-2025— SEASPINE ORTHOPEDICS CORPORATION
Class II · Ongoing
Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2024-10-29. It names one FDA 510(k) clearance: K232566. Product: Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 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..
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-29
- Firm location
- Carlsbad, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
Reason for recall
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.