Recall Z-1960-2015— Spine Wave, Inc.

Name: FDA recall Z-1960-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-04

Class II · Terminated

Class II FDA medical device recall by Spine Wave, Inc., initiated 2015-05-04, terminated 2017-01-24. It names one FDA 510(k) clearance: K072736. 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.. Reason: Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm.

Recalling firm: Spine Wave, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-04
Terminated: 2017-01-24
Firm location: Shelton, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K072736 — RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENTRhythmlink International, LLC·cleared 2008-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.