Events

Recall of Device Recall PANTA Arthrodesis Nail Support Device

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

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
    65406
  • Event Risk Class
    Class 2
  • Event Number
    Z-1736-2013
  • Event Initiated Date
    2013-05-09
  • Event Date Posted
    2013-07-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118787
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Reason
    As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the panta nail support device, integra has decided to issue this voluntary medical device correction. the misalignment can result in the inability to properly insert the screws into the panta nail and create the potential need for revision surgery.
  • Action
    Integra initiated a voluntary correction on May 9, 2013 by providing a written notification and copy of the revised Surgical Technique Manual as well as the specific highlighted sections of the manual addressing calcaneal and tibial screw alignment to all consignees that Integra records indicate have been shipped a PANTA Nail. The written notifications and Surgical Technique Manual have been delivered to US Consignees by traceable courier service and by traceable email or facsimile for Canada and Non-US Consignees. The notification informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; advises customers to review highlighted revisions of the Surgical Technique Manual to minimize the potential for misalignment of the screws and requests customers to complete and return the attached Acknowledgement Return Form.

Device

Device Recall PANTA Arthrodesis Nail Support Device
  • Model / Serial
    All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.
  • Product Description
    Integra PANTA Arthrodesis Nail System. || Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation