BEUDAMED
    FDA Recall Terminated

    PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite

    Recall: Z-0256-2009 · Initiated September 5, 2008

    Recall

    Recall Number
    Z-0256-2009
    Event Number
    49506
    Firm
    Kerr Corp
    FEI Number
    2024312
    Product Code
    EBF
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 5, 2008
    Posted
    November 25, 2008
    Terminated
    March 7, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite

    Reason

    Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.

    Action

    Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement

    Distribution

    Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.

    Quantity

    22,478 packs for all affected lots