Specialty Appliance Works, Inc. recalls Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24…
- Recall date
- March 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1505-2015
- FDA classification
- Class II
- Brand / firm
- Specialty Appliance Works, Inc.
- Sold / distributed
- Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Why it was recalled
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
Get recall alerts
Free email alert whenever Specialty Appliance Works, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Specialty Appliance Works, Inc.