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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