Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1426-2026

December 31, 2025

Class II

Product summary

Firm
Centinel Spine, Inc.
Event
Event 98282
Status
Ongoing
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-1426-2026

Official wording

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

Code information: Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled