BEUDAMED
    FDA Recall Terminated

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    Recall: Z-0791-2013 · Initiated December 17, 2012

    Recall

    Recall Number
    Z-0791-2013
    Event Number
    64160
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 17, 2012
    Posted
    February 7, 2013
    Terminated
    February 7, 2013
    Address
    4725 Calle Quetzal, Ste B, Camarillo, CA, 93012-8429

    Description

    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.

    Reason

    The tip of the Quadra Trial Broach size 0, broke during a surgery.

    Action

    Medacta sent a Urgent Safety Notification letter dated December 13, 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to check inventory for affected product and contact [email protected] for an RMA# to return items to Medacta USA. A new version of the recalled product will be provided to all affected customers. For questions call 805-437-7085 x26.

    Distribution

    US Nationwide Distribution including the states of Arizona, California, Idaho, Illinois, North Carolina, Ohio, Utah, Washington and US Virgin Islands

    Quantity

    26 pieces U.S.A. (226 pieces Worldwide)