🔍 RecallPedia

Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. 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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 9, 2015 Specialty Appliance Works Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Product No. 90870, 90876 and 90879
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Specialty Appliance Works, Inc.
Reason for Recall:
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. 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.

Product Codes/Lot Numbers:

Product No. 90870, 90876 and 90879

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1505-2015

Related Recalls

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), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/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.

Specialty Appliance Works

Class I - Dangerous

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →