Recall Z-1509-2015— 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: 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. 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
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
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.