FDA Device recall Z-3213-2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 by Centinel Spine, citing 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 evalua….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3213-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-18 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Centinel Spine |
| Distribution | US |
Product
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
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.
Identifiers
| code_info | Lot Code: UDI-DI 00843193113856; Lot 2024-0482 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3213-2024%22
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