SPINE WAVE, INC.
2 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (2)
Registered facilities (1)
- SPINE WAVE, INC. FEI 3004638600 · CT
Recalls & enforcement
- Class IITerminated2015-05-04Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
- Class IITerminated2013-05-14A component Superior endplate manufactured from a different polymer than specified
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “SPINE WAVE, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9055730-spine-wave-inc/
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