Class II

Medical Device Recall: Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Centinel Spine, Inc. · December 31, 2025

Reason for Recall

Products were mislabeled as the 6mm product but included the 5 mm product.

Distribution

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

States Affected

NATIONWIDE

Quantity Affected

20 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1426-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.