BEUDAMED
    FDA Recall Terminated

    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

    Recall: Z-2057-2012 · Initiated June 14, 2012

    Recall

    Recall Number
    Z-2057-2012
    Event Number
    62351
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 14, 2012
    Posted
    July 20, 2012
    Terminated
    April 30, 2013
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    Description

    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

    Reason

    The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

    Action

    On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.

    Distribution

    Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.

    Quantity

    15 devices