Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical... recall (Centinel Spine, Inc.)
Medical deviceClass IIOngoing
Summary: Centinel Spine, Inc. is recalling Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.. Reason: Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
What is being recalled
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Why
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
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 AZ, CA, GA, LA, MO, NY, TN, TX. (states named: Arizona, California, Georgia, Louisiana, Missouri, New York, Tennessee, Texas)
How to tell if yours is affected
Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027
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-2051-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 20, 2026 |
| Reported | May 13, 2026 |
| Company | Centinel Spine, Inc. |
| Company location | West Chester, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 30 units |
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