BEUDAMED
    FDA Recall Terminated

    ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773

    Recall: Z-0711-2008 · Initiated August 9, 2007

    Recall

    Recall Number
    Z-0711-2008
    Event Number
    38631
    Firm
    Linvatec Corp.
    FEI Number
    1017294
    Product Code
    GFF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 9, 2007
    Posted
    April 8, 2008
    Terminated
    October 1, 2009
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773

    Reason

    Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

    Action

    Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.

    Distribution

    Worldwide Distribution.

    Quantity

    1181 units