Events

Recall of Device Recall Panta Arthrodesis Nail

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
    55242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0308-2011
  • Event Initiated Date
    2010-03-01
  • Event Date Posted
    2010-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90393
  • 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
    Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (panta support device).
  • Action
    OIntegra issued Urgent Product Recall Notification letters dated 3/1/2010 to customers and distributors to notify them of the problem. Customers were requested to check their inventory to determine if they have an of the affected devices. If so, custo0mers should stop using the product. Custoemrs with the affected product should contact their local Sales Representative for assistance, or contact Integra at 800-654-2873 - 3 to obtain a returned material authorization number, and return the product to their local representative. All customers were requested to complete and return a Recall Acknowledgement and Return Form..

Device

Device Recall Panta Arthrodesis Nail
  • Model / Serial
    Catalog number 519110, Kit S/N: PAN-001, PANTAXL-015; PAN-003, PANTAXL-017; PAN-004, PANTAXL-019; PAN-006, PANTAXL-020; PAN-013, PANTAXL-022; PAN-016, PANTAXL-026; PAN-018, PANTAXL-029; PAN-021, PANTAXL-031; PAN-023, PANTAXL-032; PAN-024, PANTAXL-033; PAN-025, PANTAXL-034; PAN-027, PANTAXL-035; PAN-030, PANTAXL-036; PAN-038, PANTAXL-039; PANTAXL-008, PANTAXL-040; PANTAXL-011, PANTAXL-042 & PANTAXL-012
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, VA, WA and WI; and countries of: Australia, Austria, Belgium, Czech Republica, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
  • Product Description
    Panta Support Device Panta¿ Arthrodesis Nail Instrumentation Tray One unit per package. || The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation