Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniS...
FDA Device Recall #Z-1505-2015 — Class II — March 9, 2015
Recall Summary
| Recall Number | Z-1505-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 9, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Specialty Appliance Works, Inc. |
| Location | Cumming, GA |
| Product Type | Devices |
| Quantity | 14,428 Universal Nuts |
Product 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.
Reason for Recall
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Distribution Pattern
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Lot / Code Information
Product No. 90870, 90876 and 90879
Other Recalls from Specialty Appliance Works, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1511-2015 | Class II | TS ROC Crown Component 4UR (5/pk), TS ROC Crown... | Mar 9, 2015 |
| Z-1504-2015 | Class II | TS Herbst Nuts with Backing (10/pk) and TS Herb... | Mar 9, 2015 |
| Z-1503-2015 | Class II | MiniScope Hst ROC Crown 15 Patient Kit, and Min... | Mar 9, 2015 |
| Z-1506-2015 | Class II | M-4 Mechanism Set 16 mm and M-4 Mechanism Set 1... | Mar 9, 2015 |
| Z-1507-2015 | Class II | HTM Mechanism Set Set 16, HTH Mechanism Set Siz... | Mar 9, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.