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Spine Wave, Inc. recalls Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1
Recalled July 8, 2015 · FDA recall Z-1960-2015 · Spine Wave
Hazard
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm · FDA Class II
Units
121 units
Sold at
US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.
Description
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.
Manufacturer(s)
Spine Wave, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →