BEUDAMED
    FDA Recall Terminated

    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.

    Recall: Z-1685-2013 · Initiated February 1, 2013

    Recall

    Recall Number
    Z-1685-2013
    Event Number
    65503
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    LRZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 1, 2013
    Posted
    July 11, 2013
    Terminated
    July 25, 2013
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.

    Reason

    The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.

    Action

    The firm sent recall notification letters to all consignees via traceable email or traceable fax on 02/01/13. The firm requested that the consignees fill out and return the Recall Acknowledgement and Return Form.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.

    Quantity

    154 screwdrivers were distributed; 67 screwdriver tips were distributed.