FDA recall, , Moderate risk
Centinel Spine Prodisc C SK Total Cervical Disc Replacements
The Prodisc C SK U.S. Implant Extra Large 5mm and 6mm have a labeling mix-up.
Summary by Recall Canary from the FDA notice
What happened
Centinel Spine, Inc., of West Chester, Pennsylvania, recalled the Prodisc C SK U.S. Implant Extra Large 5mm and 6mm total cervical disc replacements because of a product labeling mix-up. The 6mm product was labeled as a 5mm, and the 5mm product was labeled as a 6mm. The recall began on March 20, 2026, and was classified by the FDA on May 1, 2026. The products were distributed in Arizona, California, Georgia, Louisiana, Missouri, New York, 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?
2 products
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Prodisc C SK U.S. Implant Extra Large 5MM.
- Model
- PDSXL5
- UDI-DI
- 00843193113979
- Lot code
- 2026-0026
Prodisc C SK U.S. Implant Extra Large 6MM.
- Model
- PDSXL6
- UDI-DI
- 00843193113986
- Lot code
- 2026-0027
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Georgia, Louisiana, Missouri, New York, 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
- 98721
- Recall numbers
- Z-2050-2026 to Z-2051-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
