Events

Recall of The TiLock Pedicle Screw System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Genesys Orthopedics 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
    67900
  • Event Risk Class
    Class 2
  • Event Number
    Z-2677-2014
  • Event Initiated Date
    2014-04-02
  • Event Date Posted
    2014-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126582
  • 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, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    The recall is being initiated because mk precision (the circular lock screw supplier) notified genesys spine that a portion (less than 20%) of the circular lock screws in lot 11406 were manufactured using stainless steel in the center post instead of the specified titanium alloy.
  • Action
    Genesys Spine sent an Urgent Medical Device Recall letter dated April 2, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were instructed to notify their customers (end users) of the recall and request that they return any affected product to Genesys Spine by completing the attached Recall Tracking Form to Genesys Spine, 1250 South Capital of Texas Hwy, Building Three, Suite 600, Austin, Texas 78746. Customers with questions were instructed to call 512-381-7070.

Device

The TiLock Pedicle Screw System
  • Model / Serial
    The devices being recalled have a catalog number of G826 and a lot number of 11406.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
  • Product Description
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. || The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
  • Manufacturer
    Genesys Orthopedics Systems, LLC

Manufacturer

Genesys Orthopedics Systems, LLC
  • Manufacturer Address
    Genesys Orthopedics Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Manufacturer Parent Company (2017)
    Genesys Orthopedics Systems LLC
  • Source
    USFDA