RecalledThisWeek Search
High risk Medical DevicesClass II

Prodisc C SK PDSXL5 Implant Recall

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

Updated March 20, 2026

Centinel Spine has recalled Prodisc C SK Extra Large cervical disc replacement implants because some 5mm implants were mislabeled as 6mm, and some 6mm implants were mislabeled as 5mm. Implanting the wrong size could result in improper fit and serious complications.

Is the Centinel Spine, Inc. recalled? Yes. This product was recalled by FDA on March 20, 2026. Details below.

What is recalled

Prodisc C SK U.S. Implant Extra Large cervical disc replacement implants, Model PDSXL5 (intended as 5mm) and the corresponding 6mm version, affected by labeling mix-up where sizes were reversed on packaging.

Am I affected

You are affected if you have had or are scheduled for cervical disc replacement surgery using a Prodisc C SK Extra Large implant (Model PDSXL5 or the 6mm equivalent). Check your surgical records or implant documentation for the Prodisc C SK model name and the actual implant size to ensure the labeling matched the product inside.

What to do right now

Contact Centinel Spine, Inc. immediately to report which implant size you received or are scheduled to receive. If you have already had surgery with this implant, contact your surgeon to verify the correct size was implanted and whether any follow-up evaluation is needed.

The hazard

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.

Brands affected

Centinel Spine, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2050-2026
Classification
Class II
Recalled
March 20, 2026
Read the official notice

Get free recall alerts

New Medical Devices recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Medical Devices recalls