BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1960-2015 · Initiated May 4, 2015

    Recall

    Recall Number
    Z-1960-2015
    Event Number
    71497
    Firm
    Spine Wave, Inc.
    FEI Number
    3004638600
    Product Code
    ETN
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    May 4, 2015
    Posted
    July 2, 2015
    Terminated
    January 24, 2017
    Address
    3 Enterprise Dr, Ste 302, Shelton, CT, 06484-4694

    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.

    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 [email protected].

    Distribution

    US Nationwide Distribution in the state of CA, FL, GA, LA, MA, MD, MI, MO, NC, NH, OH, OR, PA, TX, and VA.

    Quantity

    121 units