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 | Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm. |
| Product | Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement. |
| Quantity | 30 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX. |
| Initiated | 2026-03-20 |
| Classified | 2026-05-01 |
| Recall number | Z-2051-2026 |
| 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-2051-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98721/
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