Official recall notice
FDA DeviceClass IINotable
FDA Recall: Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Recall date
- 2026-05-13
- Brand
- Centinel Spine, Inc.
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
30 units
Product description
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.