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Recall Observatory FDA recall evidence

Device 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

Z-1509-2015

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-1509-2015

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. 91672, 91673, 91674, 91677, 91678, 91679, 91682, 91683, 91687, 91688, and 91689

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.