Events

Recall of Device Recall InterFuse Tail Traction Tool

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

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
    76275
  • Event Risk Class
    Class 2
  • Event Number
    Z-1151-2017
  • Event Initiated Date
    2017-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152615
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Fit issues have been identified with the tail traction tool (pn 9116) when used with the interfuse t tailed implant. the interfuse t tail may not fit into the thru hole in the instrument.
  • Action
    Consignees were sent via email a VTI "Advisory Notice" letter. The letter listed the Concern, Impact, Alternate Methods, Affected Lots, and Your Responsibility. Consignees were requested to acknowledge receipt of this notice, Discontinue use of the Tail Traction Tool when implanting the InterFuse T tailed implant, Notify individuals that may potentially use the device and alternate module assembly methods. Advise consignees to contact Customer Service (1-877-912-5401 in US , +-952-912-5400 outside US or customerservice@vti-spine.com to obtain a replacement instrument.

Device

Device Recall InterFuse Tail Traction Tool
  • Model / Serial
    Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN. OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,
  • Product Description
    InterFuse Tail Traction Tool, Part Number 9116. || The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. || The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.
  • Manufacturer
    Vertebral Technologies, Inc.

Manufacturer

Vertebral Technologies, Inc.
  • Manufacturer Address
    Vertebral Technologies, Inc., 13845 Industrial Park Blvd, Minneapolis MN 55441-3746
  • Manufacturer Parent Company (2017)
    Vertebral Technologies Inc.
  • Source
    USFDA