Recall Z-1426-2026 ยท MJO Prosthesis, Intervertebral Disc
Centinel Spine, Inc.
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
| Date | Feb 17, 2026 (initiated Dec 31, 2025) |
| Status | Open, Classified |
| Reason | Products were mislabeled as the 6mm product but included the 5 mm product. |
| Root cause | Process control |
| Action | On or around December 31, 2025 Phone calls were made to customers to notify them of the recall. Follow-up URGENT PRODISC C SK US IMPLANT LARGE 6MM DEVICE RECALL letters were also emailed to customers. Actions to be taken: We request that you review your inventory and return any units in your possession of this impacted lot number. We recommend monitoring any patient that has received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures. Actions to Be Taken by Centinel Spine: Centinel Spine intends to remove all remaining implants |
| Quantity | 20 units |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.