Warning
Centinel Spine Recalls Prodisc C SK U.S
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2050-2026Medical Device
Centinel Spine Recalls Prodisc C SK U.S
Centinel Spine, Inc. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Centinel Spine, Inc. initiated the recall on March 20, 2026 affecting 30 units. 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. The product was distributed in AZ, CA, GA, LA, MO, NY, TN, TX. Consumers should check their purchases and discontinue use of any affected product. Contact Centinel Spine, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.