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U.S. Department of Health and Human Services

Class 2 Device Recall SpineWave

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  Class 2 Device Recall SpineWave see related information
Date Initiated by Firm May 04, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on January 24, 2017
Recall Number Z-1960-2015
Recall Event ID 71497
510(K)Number K072736  
Product Classification Stimulator, nerve - Product Code ETN
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.
Code Information Lot Codes: 092514Z, 120814A, 011415H and 022415F
Recalling Firm/
Manufacturer		 Spine Wave, Inc.
3 Enterprise Dr Ste 302
Shelton CT 06484-4694
For Additional Information Contact Same
203-944-9494
Manufacturer 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
FDA Determined
Cause 2		 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 rsmith@spinewave.com.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ETN and Original Applicant = RHYTHMLINK INTERNATIONAL, LLC
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