Events

Recall of T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek USA 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
    66010
  • Event Risk Class
    Class 2
  • Event Number
    Z-2200-2013
  • Event Initiated Date
    2013-08-12
  • Event Date Posted
    2013-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121220
  • 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
    Screwdriver - Product Code HXX
  • Reason
    One lot of the t8 removal head had incorrect hardness specification, which could result in the t8 removal head failing during removal of the cd horizon spire and spire z spinal system implant. there is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
  • Action
    Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.

Device

T8 Removal Driver for the CD Horizon Spire and Spire Z Spinal System
  • Model / Serial
    RS12K008
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution in the state of GA, AK, WA, and CA.
  • Product Description
    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, || Product Usage: || The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA