BEUDAMED
    FDA Enforcement Class II Terminated

    Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

    Recall: Z-0207-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0207-2013
    Event ID
    63396
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 14, 2012
    Initiation Date
    September 13, 2012
    Classification Date
    November 5, 2012
    Termination Date
    September 18, 2013
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

    Reason

    A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.

    Code Info

    Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710

    Distribution

    Nationwide Distribution including AL, IL, NY, FL, TX, MI, KY, NC, CO, and GA.

    Quantity

    78