FDA DevicesClass II
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc ...
Published: May 13, 2026Recall ID: Z-2050-2026Category: devicesCountry: US
Reason for Recall / Hazard
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 Description & Identification
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Affected Products
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Additional Source Details
| Field | Value |
|---|---|
| City | West Chester |
| State | PA |
| Event id | 98721 |
| Address 1 | 900 Airport Rd Ste 3b |
| Code info | Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026 |
| Postal code | 19380-3416 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 30 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260501 |
Overview
- Recalling FirmCentinel Spine, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.