Z-1960-2015Class II

Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating...

Name: Z-1960-2015 Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating...
Creator: Spine Wave, Inc.
Published: 2015-05-04
License: https://open.fda.gov/license/

Spine Wave Inc / initiated 2015-05-04 / Terminated / root cause: packaging

FDA source

Spine Wave, Inc. began a recall of Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product... on 2015-05-04. FDA classified it as Class II and gives the reason as "Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1960-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-04
Posted: 2015-07-02
Terminated: 2017-01-24
Recalling firm: Spine Wave Inc
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.
Product code: ETN Stimulator, Nerve
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
Root cause tag: packaging
FDA root cause: Packaging change control
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].
Quantity in commerce: 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.
Product codes and lots: Lot Codes: 092514Z, 120814A, 011415H and 022415F

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1960-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1960-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code ETN

K072736Class IIRhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC / cleared 2008-01-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)