M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst… — Class II medical device recall Z-1506-2015
Terminated recall by Specialty Appliance Works, Inc., reported 2015-04-29, distributed nationwide. The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified
| Recall number | Z-1506-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Specialty Appliance Works, Inc., Cumming, GA, United States |
| Recall initiated | 2015-03-09 |
| Classified | 2015-04-22 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2017-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CH, CN, CO, DE, GB, IE, MX |
| Quantity | 14,428 universal |
Product
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1506-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.