Lower riskMedical device recall · FDA · Published December 31, 2025
Prodisc C SK Product Recall: Mislabeling of 5mm vs 6mm Disc
Centinel Spine recalls Prodisc C SK model PDSL6 due to mislabeling as 6mm but containing 5mm disc. Affected users should verify product details to avoid incorrect usage.
“Prodisc C SK Product Recall: Mislabeling of 5mm vs 6mm Disc.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50330-prodisc-c-sk-product-recall-mislabeling-of-5mm-vs-6mm. Based on FDA recall #Z-1426-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1426-2026%22&limit=1).
The FDA announced on Dec. 31, 2025, that Centinel Spine, Inc. is recalling Prodisc C SK cervical disc replacements due to mislabeling hazards. The agency issued recall number Z-1426-2026 for the voluntary Class II action.
How to tell if you have it
Brand: Prodisc
Product Name: Prodisc C SK
Model/Catalog Number: PDSL6
Lot Code: 2025-0776
UDI-DI: 00843193113924
The hazard
The products were mislabeled as the 6mm product but included the 5 mm product. The recall affects 20 units distributed nationwide in Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, and Texas.
Context
GovInfoNow's records show Centinel Spine, Inc. has 3 other recalls on record since 2021-03-05. Other recent recalls of similar products include EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (2026-02-16), Olympus POWERSEAL 5mm 23cm Sealer Recall: Incorrect Labeling Risk (2026-08-18), and Tornier Perip Screw Recall: Incorrect Labeling May Cause Surgery Delays (2025-12-19).
How to tell if you have this one
Check for the model number PDSL6 on the disc packaging or surgical documentation. The product was sold in 2025 with lot number 2025-0776.
Brand
Prodisc
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Disc Size
Confirm the disc size by checking the model number and surgical documentation to ensure it matches the intended 6mm size.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, Texas.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1426-2026 (December 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1426-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.