Medical device recalls Moderate risk

Centinel Spine, Inc. recalls Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Recall date
March 20, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2051-2026
FDA classification
Class II
Brand / firm
Centinel Spine, Inc.
Sold / distributed
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.

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