Z-1426-2026Class II

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product...

Name: Z-1426-2026 Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product...
Creator: Centinel Spine, Inc.
Published: 2025-12-31
License: https://open.fda.gov/license/

Centinel Spine, LLC / initiated 2025-12-31 / Open, Classified / root cause: manufacturing process

FDA source

Centinel Spine, Inc. began a recall of Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement... on 2025-12-31. FDA classified it as Class II and gives the reason as "Products were mislabeled as the 6mm product but included the 5 mm product". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1426-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-31
Posted: 2026-02-17
Recalling firm: Centinel Spine, LLC
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
Product code: MJO Prosthesis, Intervertebral Disc
Reason for recall: Products were mislabeled as the 6mm product but included the 5 mm product.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1426-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1426-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-17

Product code MJO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)