The Recall Desk
ModerateFDA (Devices)·Z-1509-2015·Announced 2015-04-29

Specialty Appliance Works Recalls Orthodontic Universal Nut Components

Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made 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, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Specialty Appliance Works, Inc. is recalling Universal Nut components used in orthodontic Herbst Appliances. The recall involves 14,428 Universal Nuts, including TS Crown Components 4UR, 5UR, 6UR, 4LR, 5LR, 6LR, 4UL, 5UL, 4LL, 5LL, and 6LL (5/pk). These products are identified by Product Nos. 91672, 91673, 91674, 91677, 91678, 91679, 91682, 91683, 91687, 91688, and 91689.

The recall was initiated because the Universal Nuts were manufactured using 416 SS material rather than the specified 303 SS material. A Herbst Appliance is a medical device used to affect changes in the skeletal relationship and/or occlusion of a patient, with the Universal Nut serving as a component of this appliance.

The affected products were distributed worldwide, including US nationwide (including Puerto Rico), Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and the United Kingdom. Consumers and healthcare providers should stop using these components and contact Specialty Appliance Works, Inc. for instructions on return or replacement.

The recalled product

Product
TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), T
Manufacturer
Specialty Appliance Works, Inc.
Category
Medical Device — Orthodontic Appliances
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 (11)

  • Product No. 91672
  • 91673
  • 91674
  • 91677
  • 91678
  • 91679
  • 91682
  • 91683
  • 91687
  • 91688
  • and 91689

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

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Same hazard · material substitution

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