Medium risk Medical DevicesClass II

Centinel Spine, Inc. Recall

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

Updated March 20, 2026

Centinel Spine, Inc. is recalling Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.. 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.

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 6MM. Model Number: PDSXL6. Total cervical disc replacement.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

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

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2051-2026
Classification
Class II
Recalled
March 20, 2026
Read the official notice

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