⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-05-13

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Centinel Spine, Inc.
Product
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Recall initiated
2026-03-20
Code info
Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026
Product quantity
30 units
Voluntary mandated
Voluntary: Firm initiated
City
West Chester
State
PA
Country
United States
Event id
98721
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