Recall Z-1144-2012 · OYK Ankle Arthroplasty Implantation System

Integra LifeSciences Corp.

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 a

Date	Mar 2, 2012 (initiated Nov 17, 2011)
Status	Terminated
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
Root cause	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	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 Repub
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.