Class 2 Device Recall SpineWave

• Date Initiated by Firm: May 04, 2015
• Date Posted: July 02, 2015
• Recall Status: Terminated 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: 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