Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N...
FDA Recall #Z-1426-2026 — Class II — December 31, 2025
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.
Recalling Firm
Centinel Spine, Inc. — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20 units
Distribution
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;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated