Centinel Spine product recalled over labeling errors

Recall date

December 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Centinel Spine, Inc. recalls Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: T…

Recall number

Z-1426-2026

FDA classification

Class II

Brand / firm

Centinel Spine, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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