BEUDAMED
    FDA Recall Terminated

    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.

    Recall: Z-1331-2013 · Initiated May 8, 2013

    Recall

    Recall Number
    Z-1331-2013
    Event Number
    65078
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    FYE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 8, 2013
    Posted
    May 16, 2013
    Terminated
    January 14, 2014
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.

    Reason

    LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.

    Action

    DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.,sent a " Urgent Information Medical Device Recall Notice" dated May 8, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please cease further distribution or use of the affected gloves immediately. Our records indicate your hospital purchased the affected lot. The purpose of this communication is to inform you of this recall and request acknowledgement of receipt of this letter by signing and returning the Hospital/User Facility Reconciliation Form within 10 business days of receiving this notice. Response cards should be faxed to (574) 371-4964. Please contact your DePuy Synthes Joint Reconstruction Sales Representative for assistance returning any unused affected gloves. For product related questions, please contact your local DePuy Synthes Joint Reconstruction Sales Consultant. For clinical questions from surgeons, please contact DePuy Synthes Joint Reconstructions Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.- 5 p.m. EDT). For questions about device recall information provided, please call (574)371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

    Distribution

    Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.

    Quantity

    180 gloves (120 gloves distributed in the US)