Class II

Medical Device Recall: Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Centinel Spine, Inc. · March 20, 2026

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

States Affected

NATIONWIDE

Quantity Affected

30 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2050-2026

Status: ongoing

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