BEUDAMED
    FDA Recall Terminated

    Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

    Recall: Z-0687-06 · Initiated March 3, 2006

    Recall

    Recall Number
    Z-0687-06
    Event Number
    34769
    Firm
    Kerr Corp
    FEI Number
    2024312
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2006
    Posted
    March 28, 2006
    Terminated
    March 7, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    Tooth bonding resin. Optibond Solo Plus Bottle Kit, Part Number 31514, Lot Number 429106

    Reason

    The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

    Action

    A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers.

    Distribution

    Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.

    Quantity

    85