Events

Recall of Device Recall Fixed Cervical Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genesys Orthopedic Systems, LLC.

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
    64421
  • Event Risk Class
    Class 2
  • Event Number
    Z-0921-2013
  • Event Initiated Date
    2013-02-20
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116108
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Manufacturing residue may be present on the cervical screws. use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
  • Action
    Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.

Device

Device Recall Fixed Cervical Screws
  • Model / Serial
    Part Number: GCSF37512 and Lot Number: 0243
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution including the states of: CA and TX.
  • Product Description
    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System || Product Usage: is intended for anterior screw fixation to the cervical spine.
  • Manufacturer
    Genesys Orthopedic Systems, LLC

Manufacturer

Genesys Orthopedic Systems, LLC
  • Manufacturer Address
    Genesys Orthopedic Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Source
    USFDA