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Prodisc C SK recallZ-1426-2026 · Centinel Spine, Inc. · initiated Dec 31, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Centinel Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1426-2026
Status
Open, Classified
Initiated by the company
Dec 31, 2025
Posted by the FDA
Feb 17, 2026
Recalling firm
Centinel Spine, Inc.
Quantity
20 units
Product code
MJO
FDA submissions
P070001, P070001S019, P070001S025
Distribution
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

Product description

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 (models, lots, serial numbers)

Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

45 devices cleared under P070001, P070001S019, P070001S025 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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