Recall Z-1426-2026
Centinel Spine, Inc. · initiated December 31, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;
Reason for recall
Products were mislabeled as the 6mm product but included the 5 mm product.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1426-2026
- Initiated
- December 31, 2025
- Posted by FDA
- February 17, 2026
- Product code
- MJO – Prosthesis, Intervertebral Disc
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
- Recalling firm
- Centinel Spine, Inc., West Chester, PA