Spine Wave, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1960-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 4, 2015

Date Posted: July 8, 2015

Recall Number: Z-1960-2015

Event ID: 71497

Reason for Recall:

Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm

Status: Terminated

Product Quantity: 121 units

Code Information:

Lot Codes: 092514Z, 120814A, 011415H and 022415F

Distribution Pattern:

US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated