Recall Z-2050-2026— Centinel Spine, Inc.

Name: FDA recall Z-2050-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-20

Class II · Ongoing

Class II FDA medical device recall by Centinel Spine, Inc., initiated 2026-03-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 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..

Recalling firm: Centinel Spine, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-03-20
Firm location: West Chester, PA, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.