Events

Recall of Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter

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
    61623
  • Event Risk Class
    Class 2
  • Event Number
    Z-1698-2012
  • Event Initiated Date
    2011-08-24
  • Event Date Posted
    2012-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108603
  • 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 inserters have the potential to break.
  • Action
    Genesys Orthopedic Systems, LLC decided to recall the affected product and called their customers on August 24, 2011. The firm removed the inserters from distribution from 8/24-31/2011.

Device

Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter
  • Model / Serial
    Model GP200. The four inserters were labeled with GP 200, Lot #1086.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including Florida and Texas.
  • Product Description
    Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. || The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
  • 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