BEUDAMED
    FDA Enforcement Class II 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 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-0975-2013
    Event ID
    64485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthohelix Surgical Designs Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    October 30, 2012
    Classification Date
    March 22, 2013
    Termination Date
    December 5, 2013
    Address
    1065 Medina Rd Ste 500, Medina, OH, 44256-5376, United States

    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.

    Code Info

    Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.

    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