BEUDAMED
    FDA Recall Terminated

    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.

    Recall: Z-0093-2014 · Initiated July 31, 2013

    Recall

    Recall Number
    Z-0093-2014
    Event Number
    65897
    Firm
    DePuy Spine, Inc.
    FEI Number
    1526439
    Product Code
    GCC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 31, 2013
    Posted
    October 23, 2013
    Terminated
    June 29, 2015
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE 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.

    Action

    DePuy Synthes sent an Urgent Voluntary Product Recall Notification letter dated July 30, 2013, to all affected consignees via Fed Ex overnight delivery. Consignees were informed that DePuy Spine, Inc. is voluntarily recalling all lots of the PIPELINE LS ACCESS SYSTEM Dilators (1 st, 2nd, 3rd, and 4th) and Holding Clip. They were asked to review inventory located at their facility and quarantine any products listed in this recall notice. Consignees were instructed to contact their local DePuy Synthes Spine Sales Consultant to return any inventory located within their facility. Consignees with questions were instructed to call 508-828-3583.

    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

    118 units