← FDA ENFORCEMENT
Z-1426-2026Class II

Centinel Spine, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Centinel Spine, Inc.
Product type
Device
Status
Ongoing
Report date
2026-02-25
Distribution
US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.
Firm state
PA
Product quantity
20 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Products were mislabeled as the 6mm product but included the 5 mm product.

Product description

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

Code / lot info

Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →