Class II — Spine Wave, Inc.
| Recalling firm | SPINE WAVE, INC. |
|---|---|
| Registered facility | SPINE WAVE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm |
| Product | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. |
| Quantity | 121 units |
| Distribution | US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA. |
| Initiated | 2015-05-04 |
| Classified | 2015-07-02 |
| Terminated | 2017-01-24 |
| Recall number | Z-1960-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Spine Wave, Inc. (Z-1960-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71497/
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