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.
FDA Recall Z-0742-2012 · Posted 2012-01-13
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Recalling FirmGroman Inc.
Recall StatusTerminated
Product CodeKOJ
Date Initiated2010-12-13
Date Terminated2012-01-17
Product Quantity395
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the country of Rotterdam, Netherlands.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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