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 | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations. |
| Product | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 |
| Quantity | 6 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2024-07-18 |
| Classified | 2024-09-24 |
| Recall number | Z-3213-2024 |
| 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-3213-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95164/
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