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Open, Classified

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

FDA Recall Z-1426-2026 · Posted 2026-02-17

Recalling FirmCentinel Spine, Inc.
Recall StatusOpen, Classified
Product CodeMJO
Date Initiated2025-12-31
Product Quantity20 units

Reason for Recall

Products were mislabeled as the 6mm product but included the 5 mm product.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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