Specialty Appliance Works, Inc. recalls HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst A

Recalled April 29, 2015 · FDA recall Z-1507-2015 · 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

HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 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 →