Herbst Universal Nut Recalled for Incorrect Stainless Steel Material
Specialty Appliance Works is recalling Herbst Universal Nuts because they were manufactured with 416 SS instead of the specified 303 SS.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 agency classified this as a Class II recall. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a material specification deviation without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Specialty Appliance Works, Inc. is recalling 14,428 Herbst Universal Nuts. These components are used in Herbst Appliances, which are orthodontic devices designed to affect changes in the skeletal relationship and/or occlusion of a patient.
The recall was initiated because the Universal Nuts were manufactured with 416 SS (stainless steel) rather than the specified 303 SS. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including 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 regarding the disposal or replacement of these components.
The recalled product
- Product
- Herbst Universal Nut which is used in a Herbst Appliance 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
- 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 (1)
- 1405016
Distribution
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 →Related recalls
Same manufacturer · Specialty Appliance Works, Inc.
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