FDAFDA · Food and drugs·Recall number Z-2050-2026
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Published May 13, 2026 · Recall initiated: March 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Centinel Spine, Inc.
- Distributor
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Lot
- Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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