BEUDAMED
    FDA Recall Terminated

    POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN.

    Recall: Z-1585-2011 · Initiated November 1, 2010

    Recall

    Recall Number
    Z-1585-2011
    Event Number
    57396
    Firm
    Depuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 1, 2010
    Posted
    March 7, 2011
    Terminated
    June 27, 2012
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN.

    Reason

    The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw passes through the plate.

    Action

    Urgent Information - Recall Notice letters, dated November 1, 2010 were sent to customers. The letters described the reason for recall and identified the product affected along with the affected units. The letters also provided clinical guidance and stated that the problem had been corrected and that DePuy was in the process of replenishing its inventory. Hospitals were to determine if any of the recalled components they received were still on hand, and return them immediately to their DePuy Representative or directly to DePuy for credit.

    Distribution

    Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.

    Quantity

    246 all products