Events

Recall of Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide

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

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
    61041
  • Event Risk Class
    Class 2
  • Event Number
    Z-1144-2012
  • Event Initiated Date
    2011-11-17
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107319
  • 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
    Ankle arthroplasty implantation system - Product Code OYK
  • Reason
    During 6/30/2010 to 8/17/2011 the firm received five (5) incident complaints of breakage of the threaded part of the compression guide which potentially occurred when: 1) a compression is applied between talus and tibia. (step 3 of the product description) or when 2) the surgeon screws the compression guide into the plate which most likely was attributed to improper surgical techniques used durin.
  • Action
    Integra sent a "Field Safety Notice" letter dated November 17, 2011 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review the Surgical Techinique Manual and follow the recommended guiidelines to avoid breakage. ensure that this information is distributed to their surgical teams, and fill out the enclosed "Field Safety Notice Acknowledgement and Return Form" and return to bonnie.kuzbyt@integralife.com or fax to 1-609-750-7999. For questions call 609-936-6932 or email at sean.luland@integralife.com.

Device

Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide
  • Model / Serial
    Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of; AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA & WI. Product was also shipped to the following countries: Austria, Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Saudi Arabia, South Africa, Spain, Sweden, Switzerland & United Kingdom.
  • Product Description
    Tibiaxys¿ Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. || Product Usage: || The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.