Device product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Z-2050-2026
Product summary
- Event
- Event 98721
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-2050-2026
Official wording
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.
Code information: Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
Distribution pattern: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Derived failure modes
-
Labeling or packaging
labeling mix up