Centinel Spine Recalls Prodisc C SK Cervical Disc Replacement Devices Due to Mislabeled Sizing

What Happened

Centinel Spine, Inc. has initiated a voluntary recall of its Prodisc C SK total cervical disc replacement devices. The recall was issued after it was discovered that units were mislabeled; specifically, 5mm products were incorrectly packaged and labeled as 6mm products.

Which Products Are Affected

The recall involves 20 units of the following medical device:

• Brand Name: Prodisc
• Product Name: Prodisc C SK
• Model/Catalog Number: PDSL6
• Lot Number: 2025-0776
• UDI-DI: 00843193113924

The affected units were distributed across the following states: Alabama, California, Colorado, Louisiana, New York, Oregon, Tennessee, and Texas.

What You Should Do

Centinel Spine, Inc. notified affected customers via letter starting December 31, 2025. Healthcare facilities and providers should immediately check their inventory for Lot 2025-0776. Any affected units should be quarantined and returned to the manufacturer. For further information or to coordinate a return, contact Centinel Spine, Inc. at their West Chester, Pennsylvania headquarters.

Why This Matters

Accurate labeling is critical for surgical implants. The use of an incorrectly sized cervical disc replacement could lead to surgical complications, improper fit, or the need for revision surgery if the error is not caught prior to implantation.

Source

Information provided by the FDA under Recall Number Z-1426-2026.