Events

Recall of Device Recall TraXis Fixed Trial

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
    36731
  • Event Risk Class
    Class 2
  • Event Number
    Z-0354-2007
  • Event Initiated Date
    2006-11-07
  • Event Date Posted
    2007-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49234
  • 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 implant - Product Code MQP
  • Reason
    Tip of devices may dislodge while in use during surgery.
  • Action
    All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.

Device

Device Recall TraXis Fixed Trial
  • Model / Serial
    Part #2665-1-07 (7mm), 2665-1-09 (9mm), 2665-1-11 (11mm), 2665-1-13 (13mm), 2665-1-15 (15mm).
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
  • Product Description
    TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
  • Manufacturer
    Abbott Spine

Manufacturer

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