FDA recall Z-2050-2026

Product

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

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.

Distribution

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Key facts

Status

Ongoing

Initiation date

2026-03-20

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2026