FDA recall Z-1426-2026

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

Reason for recall

Products were mislabeled as the 6mm product but included the 5 mm product.

Distribution

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

Key facts

Status

Ongoing

Initiation date

2025-12-31

Report date

2026-02-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1426-2026