BEUDAMED
    FDA Recall Terminated

    TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637

    Recall: Z-1524-06 · Initiated August 14, 2006

    Recall

    Recall Number
    Z-1524-06
    Event Number
    36222
    Firm
    Kerr Corp
    FEI Number
    2024312
    Product Code
    EMA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 14, 2006
    Posted
    September 23, 2006
    Terminated
    August 3, 2012
    Address
    1717 W Collins Ave, Orange, CA, 92867-5422

    Description

    TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637

    Reason

    Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)

    Action

    A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand

    Distribution

    Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.

    Quantity

    2,007