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Prodisc C SK Cervical Disc Implant
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MEDICAL DEVICE RECALLMODERATE

Prodisc C SK Cervical Disc Implant

Centinel Spine recalls Prodisc C SK cervical disc implants due to labeling mix-up (5mm/6mm).

What to do

If you have a Prodisc C SK implant or are scheduled for surgery, contact your healthcare provider or Centinel Spine to verify the correct size and labeling. Return any mislabeled product to the company.

Recalled
Listed
Updated
Recall No.
Z-2050-2026
Agency
FDA
Firm
Centinel Spine, Inc.
Recall ID
98721
Status
ONGOING

Recall at a glance

Quantity recalled
30 units

Why it was recalled

Centinel Spine is recalling Prodisc C SK cervical disc replacement implants due to a labeling mix-up: the 6mm implant was labeled as 5mm and the 5mm implant was labeled as 6mm. This could lead to implantation of the wrong size, potentially causing complications.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Prodisc C SK U.S. IMPLANT EXTRA LARGE

ProductModel
5MM.PDSXL5
6MM.PDSXL6

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification