FDAFDA · Food and drugs·Recall number Z-1505-2015
Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 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.
Published April 29, 2015 · Recall initiated: March 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Specialty Appliance Works, Inc.
- Distributor
- Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
- Lot
- Product No. 90870, 90876 and 90879
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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