Events

Recall of Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm

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
    70774
  • Event Risk Class
    Class 2
  • Event Number
    Z-1512-2015
  • Event Initiated Date
    2015-03-11
  • Event Date Posted
    2015-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134646
  • 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
    Orthosis, spondylolisthesis spinal fixation - Product Code MNH
  • Reason
    One lot of instruments have etched on the yoke of the pedicle screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
  • Action
    The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email orders@x-spine.com with any questions.

Device

Device Recall Xpress System Pedicle Screw Assembly, 5.5 x 55mm
  • Model / Serial
    Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: KS, NV & TX.
  • Product Description
    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
  • 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