BEUDAMED
    FDA Recall Terminated

    Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885,

    Recall: Z-0420-05 · Initiated October 13, 2004

    Recall

    Recall Number
    Z-0420-05
    Event Number
    30740
    Firm
    Harry J Bosworth Company
    FEI Number
    1410638
    Product Code
    EHY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2004
    Posted
    January 25, 2005
    Terminated
    April 24, 2006
    Address
    7227 Hamlin Ave, Skokie, IL, 60076-3901

    Description

    Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray; The Bosworth Company, 7227 North Hamlin Avenue, Skokie, IL 60076-3999; 12 trays per bag; catalog 0921885,

    Reason

    The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.

    Action

    Bosworth initiated a recall of the trays by undated letter on 10/13/04 sent to all of their customers. The letters informed the accounts that the Tray Away #3 did not meet their standards, and requested the accounts to return all of the Tray Away #3 trays 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

    13,904 trays