Device product
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit 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.
Z-1503-2015
Product summary
- Event
- Event 70787
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,428 Universal Nuts
- Official record key
device-enforcement:Z-1503-2015
Official wording
Reason: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Code information: Product No. 90127 and 90139
Distribution pattern: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.