prodisc C SK — Class II medical device recall Z-3212-2024
Ongoing recall by Centinel Spine, Inc., reported 2024-10-02, distributed nationwide. During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is
| Recall number | Z-3212-2024 |
|---|---|
| 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 | 2024-07-18 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| UPC / GTIN / UDI-DI | 00843193113856 |
| Lot numbers | 2024-0482 |
| Model numbers | PDSM5 |
Product
prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
Reason for recall
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.
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-3212-2024. 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.