Centinel Spine, LLC
4 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (4)
Registered facilities (1)
- CENTINEL SPINE, LLC FEI 3007494564 · PA
Recalls & enforcement
- Class IIOngoing2026-03-20Product 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 IIOngoing2025-12-31Products were mislabeled as the 6mm product but included the 5 mm product.
- Class IIOngoing2024-07-18During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.
- Class IITerminated2021-03-05Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the pro…
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Centinel Spine, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10026981-centinel-spine-llc/
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