FDA-Device2026-02-25Class II
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Centinel Spine, Inc.
Hazard
Products were mislabeled as the 6mm product but included the 5 mm product.
Sold states
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Affected count
20 units
Manufactured in
900 Airport Rd Ste 3b, West Chester, PA, United States
Products
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2026Original summary
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No Products were mislabeled as the 6mm product but included the 5 mm product. Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776; Distribution: US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX. Affected quantity: 20 units
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief