BEUDAMED
    FDA Recall Terminated

    Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815

    Recall: Z-0421-05 · Initiated October 13, 2004

    Recall

    Recall Number
    Z-0421-05
    Event Number
    30743
    Firm
    Harry J Bosworth Company
    FEI Number
    1410638
    Product Code
    ELW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2004
    Posted
    January 25, 2005
    Terminated
    April 26, 2006
    Address
    7227 Hamlin Ave, Skokie, IL, 60076-3901

    Description

    Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator - Blue, and one 7.5 oz. tube of Base - White, which are mixed as needed to make the registration paste; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; catalog 0921815

    Reason

    The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.

    Action

    Bosworth initiated a recall of two lots of the paste by telephone calls on 9/2/04,and expanded the recall to include a third lot of paste by undated letter on 10/13/04, sent to all of their customers. The letters informed the accounts that the accelerator component will solidify in the tube, and requested the accounts to return all of the Superbite Paste of the affected lots in stock for replacement. Follow-up letters dated 12/26/04 were sent to the consignees, requesting a response to the notification, indicating the amount of product being returned to Bosworth.

    Distribution

    Nationwide and internationally to Canada, Australia, Hong Kong, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand, Vietnam, Bahrain, Iran, Israel, Jordan, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom

    Quantity

    436 kits