BEUDAMED
    FDA Recall Terminated

    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).

    Recall: Z-1144-2012 · Initiated November 17, 2011

    Recall

    Recall Number
    Z-1144-2012
    Event Number
    61041
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    OYK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 17, 2011
    Posted
    March 2, 2012
    Terminated
    February 19, 2013
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    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).

    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 [email protected] or fax to 1-609-750-7999. For questions call 609-936-6932 or email at [email protected].

    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.

    Quantity

    168 units