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Specialty Appliance Works, Inc. recalls TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes i
Recalled April 29, 2015 · FDA recall Z-1504-2015 · 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
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) 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 →