Recall Z-1511-2015— Specialty Appliance Works, Inc.

Class II FDA medical device recall by Specialty Appliance Works, Inc., initiated 2015-03-09, terminated 2017-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS..

Recalling firm

Specialty Appliance Works, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-03-09

Terminated

2017-01-12

Firm location

Cumming, GA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.