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Centinel Spine, Inc. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.Class IIMar 20, 2026Product labeling mix up. The prodisc C SK U.S. Implant Extra |
| Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.Class IIMar 20, 2026Product labeling mix up. The prodisc C SK U.S. Implant Extra |
| Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product DescriptionClass IIDec 31, 2025Products were mislabeled as the 6mm product but included the |
| prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5Class IIJul 18, 2024During the assembly of Prodisc C, a blue discoloration was o |
| prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5Class IIJul 18, 2024During the assembly of Prodisc C, a blue discoloration was o |
| Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction Class IIMar 5, 2021Centinel Spine learned through five customer complaints that |