BEUDAMED
    FDA Recall Terminated

    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

    Recall: Z-0975-2013 · Initiated October 30, 2012

    Recall

    Recall Number
    Z-0975-2013
    Event Number
    64485
    Firm
    Orthohelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 30, 2012
    Posted
    March 22, 2013
    Terminated
    December 5, 2013
    Address
    1065 Medina Rd, Ste 500, Medina, OH, 44256-5376

    Description

    Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.

    Reason

    The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.

    Action

    OrthoHelix sent a "FIELD REMOVAL NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 330-247-1444 for questions concerning this notice.

    Distribution

    Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.

    Quantity

    Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs