FDA Device recall Z-2050-2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement by Centinel Spine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2050-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-20 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Centinel Spine |
| Distribution | US |
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
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.
Identifiers
| code_info | Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2026%22
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