FDAHealthMarch 20, 2026
Centinel Spine, Inc. — Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 20, 2026
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
What's affected?
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Brand
- Centinel Spine, Inc.
- Lot code
- 2026-0026
Additional details
Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 30 units.
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