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U.S. Department of Health and Human Services

Class 2 Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide

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  Class 2 Device Recall Tibiaxys Ankle Arthrodesis Plate Compression Guide see related information
Date Initiated by Firm November 17, 2011
Date Posted March 02, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-1144-2012
Recall Event ID 61041
Product Classification Ankle arthroplasty implantation system - Product Code OYK
Product 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).
Code Information Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH.
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Sean Luland
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 168 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.