Specialty Appliance Works, Inc. recalls TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown C…

Recall date

March 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1511-2015

FDA classification

Class II

Brand / firm

Specialty Appliance Works, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (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.