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.
FDA Recall Z-1960-2015 · Posted 2015-07-02
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Recalling FirmSpine Wave, Inc.
Recall StatusTerminated
Product CodeETN
Date Initiated2015-05-04
Date Terminated2017-01-24
Product Quantity121 units
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
Firm Action
Spine Wave sent an Urgent: Medical Device Recall letter dated June 11, 2015 to affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to acknowledge receipt
of notification by returning the enclosed Recall Notice Acknowledgement Form in the stamped envelope provided.
For questions, contact Spine Wave directly at 203-944-9494
and ask for the Recall Coordinator or by email at [email protected].
Root Cause
Packaging change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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