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Prodisc C SK recallZ-2050-2026 · Centinel Spine, Inc. · initiated Mar 20, 2026

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

Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

FDA root cause category: Labeling mix-ups

What the company is doing

Centinel Spine notified distributors on about 03/20/2026 via telephone calls and emailed letter. Surgeons were sent letters via FedEx on 03/24/2026 and by email on 03/25/2026 & 03/26/2026. Distributors were instructed to identify any affected units on hand, provide photographs documenting such, and arrange for the return of all affected units. Additionally, distributors have been instructed to diligently check prodisc C SK inventory prior to any scheduled surgery to ensure that the recalled lot numbers are not available for implantation. This includes both consignment and loaner inventory. Acknowledgment of the letter has been requested with return envelopes provided. For surgeons, they were instructed to monitor any patient(s) that have received the recalled device for any unexpected device-related symptoms throughout the regularly scheduled check-in procedures. Centinel Spine intends to remove from the market all remaining implants within the lots effected by this recall and issue a replacement product with corrected labeling for any remaining products that are subject to this recall.

Recall details

Recall number
Z-2050-2026
Status
Open, Classified
Initiated by the company
Mar 20, 2026
Posted by the FDA
May 1, 2026
Recalling firm
Centinel Spine, Inc.
Quantity
30 units
Product code
MJO
FDA submissions
P070001, P070001S019, P070001S025
Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

Product description

Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

Code information (models, lots, serial numbers)

Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 98721).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page