Specialty Appliance Works Recalls Orthodontic Universal Nuts Due to Material Error
Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.
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 hospitalizations, injuries, or illnesses. The hazard is a material specification error (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 (416 SS) rather than the specified 303 stainless steel (303 SS). Herbst Appliances are used to affect changes in the skeletal relationship and/or occlusion of a patient.
The affected products are the MiniScope Hst ROC Crown 15 Patient Kit and the MiniScope Herbst Crown 15 Patient Kit, identified by Product No. 90127 and 90139. The recall covers units distributed worldwide, including 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 instructions on how to proceed with the recall.
The recalled product
- Product
- MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit 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.
- 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. 90127 and 90139
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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Same hazard · material mis specification
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