BEUDAMED
    FDA Recall Terminated

    New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece***Pats. Pend. Groman, Inc. Adapater P/N 747 WWW.DisposableAirAbrasion.com 1-800-906-9298. The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. The Cordless Etcher handpiece is quickly re-loaded with a CO2 mini-cartridge. Each CO2 mini-cartridge provides sufficient power to run 3 EtchMaster tips. The EtchMaster tips are used to abrade tooth surfaces and prosthetic devices prior to bonding procedures.

    Recall: Z-0742-2012 · Initiated December 13, 2010

    Recall

    Recall Number
    Z-0742-2012
    Event Number
    58889
    Firm
    Groman Inc.
    FEI Number
    3004361444
    Product Code
    KOJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 13, 2010
    Posted
    January 13, 2012
    Terminated
    January 17, 2012
    Address
    4900 Nw 15th St, Unit 4494, Margate, FL, 33063-3765

    Description

    New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an operational hazard and will void the warrantee. Old Label: EtchMaster***Cordless Handpiece***Pats. Pend. Groman, Inc. Adapater P/N 747 WWW.DisposableAirAbrasion.com 1-800-906-9298. The Cordless Etcher air brush is powered by CO2 mini-cartridges to deliver pressurized gas to the EtchMaster pre-filled disposable micro air abrasive tips. The Cordless Etcher handpiece is quickly re-loaded with a CO2 mini-cartridge. Each CO2 mini-cartridge provides sufficient power to run 3 EtchMaster tips. The EtchMaster tips are used to abrade tooth surfaces and prosthetic devices prior to bonding procedures.

    Reason

    Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.

    Action

    Groman Inc. sent a "HAZARD NOTICE: IMPORTANT NOTICE ABOUT CORDLESS ETCHER HAZARD DUE TO IMPROPER USE" letter dated March 1, 2011 to all affected customers. The letter describes the product, problem, and advises the customers of the proper use of the device. Customers with questions and concerns, should contact the President of Groman Dental at 800-906-9298 ext. 709.

    Distribution

    Worldwide Distribution-USA (nationwide) and the country of Rotterdam, Netherlands.

    Quantity

    395