← FDA ENFORCEMENT
Z-2051-2026Class II

Centinel Spine, Inc.

Recalling firm
Centinel Spine, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.
Firm state
PA
Product quantity
30 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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.

Product description

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

Code / lot info

Model Number: PDSXL6; UDI-DI: 00843193113986; Lot Number: 2026-0027

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Data: U.S. FDA openFDA enforcement API. 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.