Specialty Appliance Works, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1509-2015)

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 Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/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-1509-2015

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. 91672, 91673, 91674, 91677, 91678, 91679, 91682, 91683, 91687, 91688, and 91689

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