Events

Recall of Device Recall TraXis Vue Implant System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Spine.

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
    34014
  • Event Risk Class
    Class 2
  • Event Number
    Z-0502-06
  • Event Initiated Date
    2005-11-02
  • Event Date Posted
    2006-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42907
  • 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
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • Reason
    Implants were manufactured without radiographic markers.
  • Action
    Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.

Device

Device Recall TraXis Vue Implant System
  • Model / Serial
    Lot #2010292
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
  • Product Description
    TraXis Vue Spinal Implant System, Part #2601-090921
  • Manufacturer
    Abbott Spine

Manufacturer

Abbott Spine
  • Manufacturer Address
    Abbott Spine, 12708 Riata Vista Cir # B-100, Austin TX 78727-7167
  • Source
    USFDA