BEUDAMED
    FDA Recall Terminated

    OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

    Recall: Z-1521-06 · Initiated August 29, 2006

    Recall

    Recall Number
    Z-1521-06
    Event Number
    36200
    Firm
    Kerr Corp
    FEI Number
    2024312
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2006
    Posted
    September 23, 2006
    Terminated
    August 3, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

    Reason

    Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.

    Action

    A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. 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. Periodic effectiveness checks will be conducted in order to follow up with non-responders.

    Distribution

    World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom

    Quantity

    247 Kits (50 unidose pouches/Kit)