Specialty Appliance Works Recalls Universal Nuts for Orthodontic Appliances
Specialty Appliance Works is recalling Universal Nuts for orthodontic Herbst 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, which typically indicates a temporary or medically reversible health risk. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a material specification deviation rather than a high-risk pathogen or structural failure.
Plain-English summary
Specialty Appliance Works, Inc. is recalling 14,428 Universal Nuts used as components in orthodontic Herbst Appliances. The Universal Nut is a part of an appliance used 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 stainless steel (416 SS) rather than the specified 303 stainless steel (303 SS). The affected products include HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21, and HTH Mechanism Set Size 24, identified by Product Nos. 90900, 90904, 90907, and 90910.
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 on how to handle the recalled items.
The recalled product
- Product
- HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism 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.
- 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 (4)
- Product No. 90900
- 90904
- 90907
- and 90910
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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