Device product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Z-1426-2026
Product summary
- Event
- Event 98282
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1426-2026
Official wording
Reason: Products were mislabeled as the 6mm product but included the 5 mm product.
Code information: Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
Distribution pattern: US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Derived failure modes
-
Labeling or packaging
mislabeled