FDA recall, , Moderate risk
Centinel Spine Prodisc C SK Total Cervical Disc Replacement
Prodisc C SK total cervical disc replacement was mislabeled as the 6mm product but included the 5mm product.
Summary by Recall Canary from the FDA notice
What happened
Centinel Spine, Inc., of West Chester, Pennsylvania, recalled Prodisc C SK total cervical disc replacement after the agency stated the products were mislabeled as the 6mm product but included the 5mm product. The company began the recall on December 31, 2025, and it was added to the FDA's Enforcement Report on February 17, 2026, with distribution in Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and lot code listed under your product.
Prodisc C SK
- Model number
- PDSL6
- Lot code
- 2025-0776
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, Texas.
- Company
- Centinel Spine, Inc.West Chester, Pennsylvania
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98282
- Recall number
- Z-1426-2026
- Quantity recalled
- 20 units
All recalls from Centinel Spine, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
