Events

Recall of Device Recall SpineWave

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spine Wave, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71497
  • Event Risk Class
    Class 2
  • Event Number
    Z-1960-2015
  • Event Initiated Date
    2015-05-04
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137960
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, nerve - Product Code ETN
  • Reason
    Mislabeled outer carton: monopolar probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm.
  • 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.

Device

Device Recall SpineWave
  • Model / Serial
    Lot Codes: 092514Z, 120814A, 011415H and 022415F
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 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.
  • Manufacturer
    Spine Wave, Inc.

Manufacturer

Spine Wave, Inc.
  • Manufacturer Address
    Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
  • Manufacturer Parent Company (2017)
    Spine Wave Inc
  • Source
    USFDA