Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM.
- Recalling company
- Centinel Spine, Inc.
- Product
- Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 20, 2026
- Reported
- May 13, 2026
- Distribution
- US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
- Status
- Ongoing
- Quantity
- 30 units
- Lot / codes
- Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
- Company location
- West Chester, PA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2050-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2050-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.