The Recall Desk
ModerateFDA (Devices)·Z-1511-2015·Announced 2015-04-29

Specialty Appliance Works Recalls Orthodontic Universal Nut Components

Specialty Appliance Works is recalling TS ROC Crown Components because the Universal Nut was 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. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a material specification deviation without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Specialty Appliance Works, Inc. is recalling TS ROC Crown Components, which include Universal Nuts used as components of orthodontic Herbst Appliances. The recall involves 14,428 Universal Nuts. These products were distributed worldwide, including in the United States, Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and the United Kingdom.

The recall was initiated because the Universal Nut was manufactured using 416 SS material rather than the specified 303 SS material. Herbst Appliances are used to affect changes in the skeletal relationship and/or occlusion of a patient.

Consumers and healthcare providers should stop using the affected Universal Nuts and contact Specialty Appliance Works, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk),
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 (20)

  • Product No. 91720
  • 91721
  • 91722
  • 91723
  • 91724
  • 91725
  • 91726
  • 91727
  • 91728
  • 91729
  • 91730
  • 91731
  • 91732
  • 91733
  • 91734
  • 91735
  • 91736
  • 91737
  • 91738
  • and 91739

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 →

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