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Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Recalled May 13, 2026 · FDA recall Z-2050-2026 · Centinel Spine
Hazard
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. · FDA Class II
Units
30 units
Sold at
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Description
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.
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Manufacturer(s)
Centinel Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →