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CLASS II · ModerateFDA

Centinel Spine, Inc. recalls Brand Name: Prodisc Product Name: Prodisc C SK

📅 Dec 31, 2025 · 📍 Nationwide
Recalling company
Centinel Spine, Inc.
Product
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Reason
Products were mislabeled as the 6mm product but included the 5 mm product.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 31, 2025
Reported
Feb 25, 2026
Distribution
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Status
Ongoing
Quantity
20 units
Lot / codes
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
Company location
West Chester, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-1426-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1426-2026 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.