Class 2 Device Recall Prodisc C SK

• Date Initiated by Firm: December 31, 2025
• Date Posted: February 17, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1426-2026
• Recall Event ID: 98282
• PMA Number: P070001 P070001S019 P070001S025
• Product Classification: Prosthesis, intervertebral disc - Product Code MJO
• Product: Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
• Code Information: Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776
• FEI Number: 3007494564
• Recalling Firm/ Manufacturer: Centinel Spine, Inc.; 900 Airport Rd Ste 3b; West Chester PA 19380-3416
• For Additional Information Contact: 888-736-2724
• Manufacturer Reason for Recall: Products were mislabeled as the 6mm product but included the 5 mm product.
• FDA Determined 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 effected by this recall from the market and issue a replacement product with corrected labeling for any remaining products in the Distributors possession that are subject to this recall.
• Quantity in Commerce: 20 units
• Distribution: US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MJO