AOA Mini RPE Screw Assembly — Class II medical device recall Z-2195-2013
Terminated recall by Sybron Dental Specialties, reported 2013-09-18, distributed nationwide. The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joinin
| Recall number | Z-2195-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sybron Dental Specialties, Orange, CA, United States |
| Recall initiated | 2013-06-06 |
| Classified | 2013-09-12 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2013-09-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 1,091 |
| Model numbers | 3000-0010, 3000-0011, 3000-0012, 3000-0040, 3000-0042, 3000-0045, 3000-0046, 3000-0047, 3000-0050, 3000-0094, 3000-0097 |
Product
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.
Reason for recall
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.
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-2195-2013. 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.