Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number:… — Class II medical device recall Z-1426-2026
Ongoing recall by Centinel Spine, Inc., reported 2026-02-25, distributed nationwide. Products were mislabeled as the 6mm product but included the 5 mm product.
| Recall number | Z-1426-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Centinel Spine, Inc., West Chester, PA, United States |
| Recall initiated | 2025-12-31 |
| Classified | 2026-02-17 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00843193113924 |
| Lot numbers | 2025-0776 |
| Model numbers | PDSL6 |
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
Reason for recall
Products were mislabeled as the 6mm product but included the 5 mm product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1426-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.