BEUDAMED
    FDA Recall Terminated

    Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients 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 for correction of deformity.

    Recall: Z-0348-2010 · Initiated July 21, 2009

    Recall

    Recall Number
    Z-0348-2010
    Event Number
    52852
    Firm
    Orthopediatrics Corp
    FEI Number
    3006460162
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 21, 2009
    Posted
    May 12, 2010
    Terminated
    October 25, 2010
    Address
    210 N Buffalo St, Warsaw, IN, 46580-2730

    Description

    Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients 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 for correction of deformity.

    Reason

    The potential exists for the nails to fracture during insertion of the nail.

    Action

    Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.

    Distribution

    Nationwide.

    Quantity

    23 of all products