Specialty Appliance Works, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1504-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 9, 2015

Date Posted: April 29, 2015

Recall Number: Z-1504-2015

Event ID: 70787

Reason for Recall:

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Status: Terminated

Product Quantity: 14,428 Universal Nuts

Code Information:

Product No. 90869 and 90875

Distribution Pattern:

Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated