Z-1426-2026 Class II Ongoing
FDA device recall Z-1426-2026 was initiated by Centinel Spine, Inc. on December 31, 2025 and is designated Class II. Reason for recall: Products were mislabeled as the 6mm product but included the 5 mm product. The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Reason for Recall
Products were mislabeled as the 6mm product but included the 5 mm product.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Code Information
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;