Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software... recall (Centinel Spine, Inc.)
Medical deviceClass IIOngoing
Summary: Centinel Spine, Inc. is recalling 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.
What is being recalled
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
Why
Products were mislabeled as the 6mm product but included the 5 mm product.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX. (states named: Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, Texas)
How to tell if yours is affected
Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1426-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 31, 2025 |
| Reported | February 25, 2026 |
| Company | Centinel Spine, Inc. |
| Company location | West Chester, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20 units |
More recalls from Centinel Spine, Inc. · all medical device recalls · recalls from December 2025