BEUDAMED
    FDA Recall Terminated

    MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA

    Recall: Z-0712-05 · Initiated March 7, 2005

    Recall

    Recall Number
    Z-0712-05
    Event Number
    31604
    Firm
    Porex Surgical, Inc.
    FEI Number
    1000131961
    Product Code
    HPZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2005
    Posted
    April 16, 2005
    Terminated
    August 17, 2005
    Address
    15 Dart Rd, Newnan, GA, 30265-1017

    Description

    MEDPOR Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 * Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA

    Reason

    The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres

    Action

    On 03/07/2005 and 03/08/2005 consignees were notified via email and telephone. A follow up letter was being sent.

    Distribution

    AZ, IL, NJ and Korea

    Quantity

    30 units