Events

Recall of Device Recall Calix P PEEK Lumbar System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X Spine Systems 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
    74397
  • Event Risk Class
    Class 2
  • Event Number
    Z-0124-2017
  • Event Initiated Date
    2016-05-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147381
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • 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.

Device

Device Recall Calix P PEEK Lumbar System
  • Model / Serial
    Size, 22mm x 10mm x 6mm, Part #:, X034-0990, Lot #:, 015641-2-1, 015641-2-1R, 015857-24-1, 020316, 020329, 020746, 19894, UP1009, UPI002, UPI005, UPI008 & Size, 22mm x 10mm x 10mm, Part #:, X034-0994, Lot #:, 015641-3-1, 015641-3-1R,015857-25-1, 020317, 020330, 020747, UPI001, UPI004, UPI007.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Calix P PEEK Lumbar System, PLIF Rasp
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Manufacturer Address
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Manufacturer Parent Company (2017)
    X-Spine Systems, Inc
  • Source
    USFDA