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Specialty Appliance Works, Inc. recalls MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect
Recalled April 29, 2015 · FDA recall Z-1503-2015 · Specialty Appliance Works
Hazard
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. · FDA Class II
Units
14,428 Universal Nuts
Sold at
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Description
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Product
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer(s)
Specialty Appliance Works, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →