Recall Z-1502-2015— Specialty Appliance Works, Inc.
Class II · Terminated
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: Herbst Universal Nut which is used in a Herbst Appliance 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
Product description
Herbst Universal Nut which is used in a Herbst Appliance 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 for recall
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Data sourced from openFDA. This site is unofficial and independent of the FDA.