BEUDAMED
    FDA Recall Terminated

    Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ

    Recall: Z-1034-2009 · Initiated January 16, 2009

    Recall

    Recall Number
    Z-1034-2009
    Event Number
    50899
    Firm
    Integra LifeSciences Corp
    FEI Number
    1121308
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    January 16, 2009
    Posted
    March 6, 2009
    Terminated
    June 25, 2009
    Address
    105 Morgan Ln, Plainsboro, NJ, 08536-3339

    Description

    Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ

    Reason

    Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

    Action

    Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.

    Distribution

    Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.

    Quantity

    88 units