BEUDAMED
    FDA Enforcement Class II Terminated

    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    Recall: Z-0096-2014 · Reported November 6, 2013

    Enforcement

    Recall Number
    Z-0096-2014
    Event ID
    65897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    October 28, 2013
    Termination Date
    June 29, 2015
    Address
    325 Paramount Dr, N/A, Raynham, MA, 02767-5199, United States

    Description

    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    Reason

    Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.

    Code Info

    287105018

    Distribution

    Nationwide Distribution including the states of AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, and WY.

    Quantity

    100 units