BEUDAMED
    FDA Enforcement Class II Terminated

    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

    Recall: Z-1536-2013 · Reported June 19, 2013

    Enforcement

    Recall Number
    Z-1536-2013
    Event ID
    65091
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    June 19, 2013
    Initiation Date
    April 19, 2013
    Classification Date
    June 12, 2013
    Termination Date
    September 19, 2013
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

    Reason

    Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

    Code Info

    All lot numbers are affected. Catalog No. 00-1200-1002

    Distribution

    USA Nationwide Distribution

    Quantity

    130 devices were shipped