Class II — Centinel Spine, Inc.
| Recalling firm | Centinel Spine, LLC |
|---|---|
| Registered facility | CENTINEL SPINE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Products were mislabeled as the 6mm product but included the 5 mm product. |
| 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 |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX. |
| Initiated | 2025-12-31 |
| Classified | 2026-02-17 |
| Recall number | Z-1426-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Centinel Spine, Inc. (Z-1426-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98282/
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