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Recall Observatory FDA recall evidence

Device product

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.

Z-1505-2015

March 09, 2015

Class II

Product summary

Firm
Specialty Appliance Works, Inc.
Event
Event 70787
Status
Terminated
Classification
Class II
Quantity
14,428 Universal Nuts
Official record key
device-enforcement:Z-1505-2015

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. 90870, 90876 and 90879

Distribution pattern: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.