Specialty Appliance Works Recalls Universal Nuts for Incorrect Material Composition
Specialty Appliance Works is recalling Universal Nuts used in orthodontic Herbst Appliances because they were manufactured 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 involves a material specification deviation (416 SS vs 303 SS) without explicit evidence of significant harm, 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 M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm Herbst Appliances. These appliances are used to affect changes in the skeletal relationship and/or occlusion of a patient.
The recall was initiated because the Universal Nuts were made with 416 stainless steel (416 SS) rather than the specified 303 stainless steel (303 SS). The affected products are identified by Product No. 90885 and 90888.
The recall covers worldwide distribution, including the United States (nationwide including Puerto Rico), Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and the United Kingdom. Consumers and healthcare providers should contact Specialty Appliance Works, Inc. for further instructions regarding the return or replacement of these components.
The recalled product
- Product
- M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm 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. 90885 and 90888
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.
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