Specialty Appliance Works Recalls Universal Nuts for Herbst Appliances
Specialty Appliance Works is recalling Universal Nuts used in Herbst orthodontic appliances 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a material specification deviation (416 SS vs 303 SS) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Specialty Appliance Works, Inc. is recalling 14,428 Universal Nuts, which are components of orthodontic Herbst Appliances. The recall was initiated because the Universal Nuts were manufactured using 416 stainless steel rather than the specified 303 stainless steel.
The affected products are identified by Product No. 91522 and 91523. These components were distributed worldwide, including in the United States (nationwide including Puerto Rico), Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and the United Kingdom.
Consumers and healthcare providers should stop using the affected Universal Nuts and contact Specialty Appliance Works, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (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.
- Manufacturer
- Specialty Appliance Works, Inc.
- 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)
- Product No. 91522 and 91523
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
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