Events

Recall of Device Recall KYPHON(R) Directional Bone Filler Device

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
    77352
  • Event Risk Class
    Class 2
  • Event Number
    Z-2247-2017
  • Event Initiated Date
    2017-05-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155810
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Reason
    The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
  • Action
    Medtronic distributed a voluntary removal notice (Attachment I) via FedEx courier service to impacted U.S. consignees on 17 May 2017. Communications to impacted consignees outside the United States are currently ongoing per each geographies local procedures. The consignees were directed to do the following: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via fax to 763-367-8134, or via e-mail to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.

Device

Device Recall KYPHON(R) Directional Bone Filler Device
  • Model / Serial
    All Lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    worldwide
  • Product Description
    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • 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