Recall Z-2050-2026 ยท MJO Prosthesis, Intervertebral Disc
Centinel Spine, Inc.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
| Date | May 1, 2026 (initiated Mar 20, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Centinel Spine notified distributors on about 03/20/2026 via telephone calls and emailed letter. Surgeons were sent letters via FedEx on 03/24/2026 and by email on 03/25/2026 & 03/26/2026. Distributors were instructed to identify any affected units on hand, provide photographs documenting such, and arrange for the return of all affected units. Additionally, distributors have been instructed to diligently check prodisc C SK inventory prior to any scheduled surgery to ensure that the recalled lot numbers are not available for implantation. This includes both consignment and loaner inventory. A |
| Quantity | 30 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.