The Recall Desk
ModerateFDA (Devices)·Z-1505-2015·Announced 2015-04-29

Specialty Appliance Works Recalls MiniScope Mechanical Set Universal Nuts

Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a material specification deviation (416 SS vs 303 SS) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Specialty Appliance Works, Inc. is recalling 14,428 Universal Nuts, which are components of the Specialty MiniScope Mech. Set in sizes 18, 21, and 24. The affected products are identified by Product No. 90870, 90876, and 90879. The recall is due to the Universal Nuts being manufactured with 416 stainless steel rather than the specified 303 stainless steel.

The Specialty MiniScope Mech. Set is a Herbst Appliance used to affect changes in the skeletal relationship and/or occlusion of a patient. The affected Universal Nuts were distributed worldwide, including in the United States (nationwide including Puerto Rico), Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and the United Kingdom.

The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled components.

The recalled product

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
Manufacturer
Specialty Appliance Works, Inc.
Category
Medical Device — Orthodontic Appliances
Hazard
Affected units
14,428

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product No. 90870
  • 90876 and 90879

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 10 recalled by Specialty Appliance Works, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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