Events

Recall of Device Recall VisuALIF

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spine Smith Holdings, 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
    65999
  • Event Risk Class
    Class 2
  • Event Number
    Z-2258-2013
  • Event Initiated Date
    2013-07-31
  • Event Date Posted
    2013-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121169
  • 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 product has the potential to be laser marked as a medium when it actually is a small.
  • Action
    The firm decided to remove this lot and verify all of the markings. A stock sweep for mis-marked parts was performed at the time and it is not known why this lot is identified, however an additional stock sweep of all PEEK products from all product lines was performed beginning 07/31/2013 and no additional lots were identified.

Device

Device Recall VisuALIF
  • Model / Serial
    Part Number: 0301-1410, Lot 53AR
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in FL.
  • Product Description
    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. || Intended to be implanted via an open anterior approach.
  • Manufacturer
    Spine Smith Holdings, LLC

Manufacturer

Spine Smith Holdings, LLC
  • Manufacturer Address
    Spine Smith Holdings, LLC, 93 Red River St, Austin TX 78701-4216
  • Manufacturer Parent Company (2017)
    Spinesmith Holdings Llc
  • Source
    USFDA