BEUDAMED
    FDA Recall Terminated

    Calix P PEEK Lumbar System, PLIF Rasp

    Recall: Z-0124-2017 · Initiated May 17, 2016

    Recall

    Recall Number
    Z-0124-2017
    Event Number
    74397
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 17, 2016
    Terminated
    April 4, 2019
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    Description

    Calix P PEEK Lumbar System, PLIF Rasp

    Reason

    The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.

    Action

    Consignees will be notified via email and courier and will be instructed to return the affected product. Upon receipt of the recalled trays, the trials and rasps will be removed from the tray and quarantined for evenutal destruction.

    Distribution

    Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.

    Quantity

    182 units