Specialty Appliance Works Recalls Orthodontic Herbst Appliance Nuts
Specialty Appliance Works is recalling TS Herbst Nuts 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 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 TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk). These products are components of the orthodontic Herbst Appliance, which is used to affect changes in the skeletal relationship and/or occlusion of a patient.
The recall was initiated because the Universal Nut was made with 416 stainless steel (416 SS) rather than the specified 303 stainless steel (303 SS). The affected products are identified by Product No. 90869 and 90875.
The recall involves 14,428 Universal Nuts. Distribution was 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
- TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/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. 90869 and 90875
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.
See all →- ModerateSpecialty Appliance Works Recalls Universal Nuts for Incorrect Material Composition
FDA (Devices) · 2015-04-29
- ModerateSpecialty Appliance Works Recalls MiniScope Mechanical Set Universal Nuts
FDA (Devices) · 2015-04-29
- ModerateSpecialty Appliance Works Recalls Orthodontic Universal Nut Components
FDA (Devices) · 2015-04-29
- ModerateSpecialty Appliance Works Recalls Orthodontic Universal Nut Components
FDA (Devices) · 2015-04-29
- ModerateHerbst Universal Nut Recalled for Incorrect Stainless Steel Material
FDA (Devices) · 2015-04-29
Same hazard · material specification
See all →- HighReusable Oral Syringe Recalled for Unapproved Plunger Material
FDA (Devices) · 2022-10-26
- ModerateZimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns
FDA (Devices) · 2019-05-29
- ModerateZimmer GmbH Recalls Cannulated Drills Due to Material Specification Concerns
FDA (Devices) · 2019-05-29
- ModerateSpecialty Appliance Works Recalls Universal Nuts for Incorrect Stainless Steel Material
FDA (Devices) · 2015-04-29
- ModerateSpecialty Appliance Works Recalls Universal Nuts for Orthodontic Appliances
FDA (Devices) · 2015-04-29