Z-2051-2026Class II

Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement

Name: Z-2051-2026 Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement
Creator: Centinel Spine, Inc.
Published: 2026-03-20
License: https://open.fda.gov/license/

Centinel Spine, LLC / initiated 2026-03-20 / Open, Classified / root cause: labeling and UDI

FDA source

Centinel Spine, Inc. began a recall of Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement on 2026-03-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2051-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-20
Posted: 2026-05-01
Recalling firm: Centinel Spine, LLC
Product: Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Product code: MJO Prosthesis, Intervertebral Disc
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 30 units
Distribution: US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Product codes and lots: Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2050-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-2051-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

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)