BEUDAMED
    FDA Recall Terminated

    Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

    Recall: Z-0013-2011 · Initiated June 15, 2010

    Recall

    Recall Number
    Z-0013-2011
    Event Number
    56026
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 15, 2010
    Posted
    October 6, 2010
    Terminated
    November 30, 2011
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

    Reason

    Firm discovered that some of their straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring).

    Action

    On June 3, 2010, an "Alert: Femoral Broach Handle Repair" went out to the entire sales force/customers via "Sales Mail" and posted to the DePuy Internal website. The Alert stated that "We have discovered that some of our straight broach handles are experiencing early failure due to a weakened handle locking mechanism (Leaf Spring). As you perform routine maintenance on your sets, if you have any of these broaches stamped with the lot numbers listed, it is recommended you have them sent in to be reworked with a new spring device." Send the broach handles to: DePuy Orthopaedics Attn: Repairs 700 Orthopaedic Dr Warsaw, IN 46581 Please include return shipping information If you have any questions regarding this information or need additional information, call 574-372-7333.

    Distribution

    Nationwide distribution: AR, AZ, CA, FL, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NV, NY, OH, PA, TN, VA, and WI.

    Quantity

    8358